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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01609296
Registration number
NCT01609296
Ethics application status
Date submitted
24/05/2012
Date registered
31/05/2012
Titles & IDs
Public title
IN.PACT Global Clinical Study
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Scientific title
The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral™ Drug-Eluting Balloon.
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Secondary ID [1]
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10048613
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease
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Condition category
Condition code
Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - IN.PACT Admiral™ Drug Eluting Balloon
Experimental: IN.PACT Admiral DEB - The subjects in this trial will be treated with the IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon (hereinafter referred as "IN.PACT Admiral™ DEB")manufactured by Medtronic. The IN.PACT Admiral™ is a CE (Conformité Europeénne, European Confirmity) marked medical device utilized within its intended use in the IN.PACT Global trial.
Treatment: Devices: IN.PACT Admiral™ Drug Eluting Balloon
IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Clinical Cohort ITT - Primary Effectiveness Endpoint
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Assessment method [1]
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Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
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Timepoint [1]
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12 months
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Primary outcome [2]
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Clinical Cohort ITT - Primary Safety Endpoint
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Assessment method [2]
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A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 12 months post-index procedure.
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Timepoint [2]
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12 months
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Primary outcome [3]
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Imaging Cohort ITT - Primary Effectiveness Endpoint
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Assessment method [3]
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Primary Patency within 12 months post-index procedure, which is defined as:
* Freedom from clinically-driven TLR and
* Freedom from restenosis as determined by DUS Peak Systolic Velocity Ratio (PSVR) = 2.4.
* Restenosis determined by either PSVR \>2.4 as assessed by an independent DUS core lab or \>50% stenosis as assessed by an independent angiographic core lab.
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Timepoint [3]
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12 months
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Primary outcome [4]
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150mm DEB ITT Cohort - Primary Effectiveness Endpoint
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Assessment method [4]
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Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as:
• Any re-intervention within the target lesion(s) due to symptoms or drop of ABI = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
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Timepoint [4]
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12 months
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Secondary outcome [1]
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Clinical Cohort ITT - MAEs
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Assessment method [1]
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MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR (Target Vessel Revascularization), major target limb amputation, thrombosis at the target lesion site.
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Timepoint [1]
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12 months
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Secondary outcome [2]
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Clinical Cohort ITT - TLR
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Assessment method [2]
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Any Target lesion revascularisation
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Timepoint [2]
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12 months
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Secondary outcome [3]
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0
Clinical Cohort ITT - TVR
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Assessment method [3]
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0
Any Target vessel revascularisation
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Timepoint [3]
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0
12 months.
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Secondary outcome [4]
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0
Clinical Cohort ITT - Device Success
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Assessment method [4]
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Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)
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Timepoint [4]
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0
Index-procedure
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Secondary outcome [5]
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Clinical Cohort ITT - Clinical Success
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Assessment method [5]
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Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge
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Timepoint [5]
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0
prior to discharge
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Secondary outcome [6]
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0
Clinical Cohort ITT - MAEs
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Assessment method [6]
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0
MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
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Timepoint [6]
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60 months
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Secondary outcome [7]
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0
Clinical Cohort ITT - Clinically-driven TLR
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Assessment method [7]
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0
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
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Timepoint [7]
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0
60 months
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Secondary outcome [8]
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0
Clinical Cohort ITT - TVR
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Assessment method [8]
0
0
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Timepoint [8]
0
0
60 months
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Secondary outcome [9]
0
0
Clinical Cohort ITT - TLR
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Assessment method [9]
0
0
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Timepoint [9]
0
0
60 months
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Secondary outcome [10]
0
0
Clinical Cohort ITT - Time to First Clinically-driven TLR (Days)
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Assessment method [10]
0
0
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Timepoint [10]
0
0
60 months
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Secondary outcome [11]
0
0
Clinical Cohort ITT - MAEs
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Assessment method [11]
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0
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days.
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Timepoint [11]
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0
30 days
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Secondary outcome [12]
0
0
Clinical Cohort ITT - MAEs
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Assessment method [12]
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0
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site
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Timepoint [12]
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6 Months
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Secondary outcome [13]
0
0
Clinical Cohort ITT - MAEs
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Assessment method [13]
0
0
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
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Timepoint [13]
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24 Months
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Secondary outcome [14]
0
0
Clinical Cohort ITT - MAEs
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Assessment method [14]
0
0
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
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Timepoint [14]
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36 Months
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Secondary outcome [15]
0
0
Clinical Cohort ITT - MAEs
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Assessment method [15]
0
0
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
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Timepoint [15]
0
0
48 Months
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Secondary outcome [16]
0
0
Clinical Cohort ITT - Clinically-driven TLR
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Assessment method [16]
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0
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
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Timepoint [16]
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0
30 days
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Secondary outcome [17]
0
0
Clinical Cohort ITT - Clinically-driven TLR
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Assessment method [17]
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0
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
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Timepoint [17]
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0
6 Months
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Secondary outcome [18]
0
0
Clinical Cohort ITT - Clinically-driven TLR
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Assessment method [18]
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0
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
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Timepoint [18]
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0
24 Months
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Secondary outcome [19]
0
0
Clinical Cohort ITT - Clinically-driven TLR
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Assessment method [19]
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0
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
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Timepoint [19]
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0
36 Months
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Secondary outcome [20]
0
0
Clinical Cohort ITT - Clinically-driven TLR
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Assessment method [20]
0
0
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
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Timepoint [20]
0
0
48 Months
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Secondary outcome [21]
0
0
Clinical Cohort ITT - TLR
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Assessment method [21]
0
0
Any Target lesion revascularisation
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Timepoint [21]
0
0
6 Months
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Secondary outcome [22]
0
0
Clinical Cohort ITT - TLR
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Assessment method [22]
0
0
Any Target lesion revascularisation
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Timepoint [22]
0
0
24 Months
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Secondary outcome [23]
0
0
Clinical Cohort ITT - TLR
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Assessment method [23]
0
0
Any Target lesion revascularisation
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Timepoint [23]
0
0
36 Months
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Secondary outcome [24]
0
0
Clinical Cohort ITT - TLR
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Assessment method [24]
0
0
Any Target lesion revascularisation
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Timepoint [24]
0
0
48 Months
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Secondary outcome [25]
0
0
Clinical Cohort ITT - TVR
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Assessment method [25]
0
0
Any Target lesion revascularisation
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Timepoint [25]
0
0
24 Months
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Secondary outcome [26]
0
0
Clinical Cohort ITT - TVR
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Assessment method [26]
0
0
Any Target lesion revascularisation
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Timepoint [26]
0
0
36 Months
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Secondary outcome [27]
0
0
Clinical Cohort ITT - TVR
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Assessment method [27]
0
0
Any Target lesion revascularisation
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Timepoint [27]
0
0
48 Months
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Secondary outcome [28]
0
0
Clinical Cohort ITT - TVR
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Assessment method [28]
0
0
Any Target lesion revascularisation
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Timepoint [28]
0
0
6 Months
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Secondary outcome [29]
0
0
Clinical Cohort ITT - Time to All-cause Mortality Through 60 Months Post-index Procedure.
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Assessment method [29]
0
0
All-cause mortality is reported by using the survival estimate of all cause mortality through 60 months
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Timepoint [29]
0
0
60 months
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Secondary outcome [30]
0
0
Clinical Cohort ITT - Primary Sustained Clinical Improvement
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Assessment method [30]
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0
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
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Timepoint [30]
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0
6 Months
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Secondary outcome [31]
0
0
Clinical Cohort ITT - Primary Sustained Clinical Improvement
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Assessment method [31]
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0
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
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Timepoint [31]
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0
12 Months
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Secondary outcome [32]
0
0
Clinical Cohort ITT - Primary Sustained Clinical Improvement
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Assessment method [32]
0
0
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
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Timepoint [32]
0
0
24 Months
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Secondary outcome [33]
0
0
Clinical Cohort ITT - Primary Sustained Clinical Improvement
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Assessment method [33]
0
0
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
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Timepoint [33]
0
0
36 Months
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Secondary outcome [34]
0
0
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
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Assessment method [34]
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0
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
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Timepoint [34]
0
0
6 Months
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Secondary outcome [35]
0
0
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
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Assessment method [35]
0
0
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
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Timepoint [35]
0
0
12 Months
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Secondary outcome [36]
0
0
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
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Assessment method [36]
0
0
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
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Timepoint [36]
0
0
24 Months
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Secondary outcome [37]
0
0
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
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Assessment method [37]
0
0
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
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Timepoint [37]
0
0
36 Months
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Secondary outcome [38]
0
0
Clinical Cohort ITT - Immediate Hemodynamic Improvement at Post-index Procedure
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Assessment method [38]
0
0
Immediate hemodynamic improvement is defined as an ABI improvement of = 0.1 or to an ABI = 0.9
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Timepoint [38]
0
0
Post procedure
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Secondary outcome [39]
0
0
Clinical Cohort ITT - Sustained Hemodynamic Improvement
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Assessment method [39]
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0
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with = 0.1 as compared to baseline values or to an ABI = 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
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Timepoint [39]
0
0
6 Months
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Secondary outcome [40]
0
0
Clinical Cohort ITT - Sustained Hemodynamic Improvement
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Assessment method [40]
0
0
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with = 0.1 as compared to baseline values or to an ABI = 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
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Timepoint [40]
0
0
12 Months
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Secondary outcome [41]
0
0
Clinical Cohort ITT - Sustained Hemodynamic Improvement
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Assessment method [41]
0
0
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with = 0.1 as compared to baseline values or to an ABI = 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
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Timepoint [41]
0
0
24 Months
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Secondary outcome [42]
0
0
Clinical Cohort ITT - Sustained Hemodynamic Improvement
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Assessment method [42]
0
0
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with = 0.1 as compared to baseline values or to an ABI = 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
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Timepoint [42]
0
0
36 Months
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Secondary outcome [43]
0
0
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
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Assessment method [43]
0
0
Query!
Timepoint [43]
0
0
6 Months
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Secondary outcome [44]
0
0
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
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Assessment method [44]
0
0
Query!
Timepoint [44]
0
0
12 Months
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Secondary outcome [45]
0
0
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
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Assessment method [45]
0
0
Query!
Timepoint [45]
0
0
24 Months
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Secondary outcome [46]
0
0
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
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Assessment method [46]
0
0
Query!
Timepoint [46]
0
0
36 Months
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Secondary outcome [47]
0
0
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
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Assessment method [47]
0
0
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
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Timepoint [47]
0
0
6 Months
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Secondary outcome [48]
0
0
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
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Assessment method [48]
0
0
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
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Timepoint [48]
0
0
12 Months
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Secondary outcome [49]
0
0
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
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Assessment method [49]
0
0
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
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Timepoint [49]
0
0
24 Months
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Secondary outcome [50]
0
0
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
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Assessment method [50]
0
0
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
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Timepoint [50]
0
0
36 Months
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Secondary outcome [51]
0
0
Clinical Cohort ITT - Procedural Success
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Assessment method [51]
0
0
Procedural Success is defined as residual stenosis of = 50% (non-stented subjects) or = 30% (stented subjects) by visual estimate
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Timepoint [51]
0
0
at procedure
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Secondary outcome [52]
0
0
Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 2.0) of the Target Lesion
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Assessment method [52]
0
0
Query!
Timepoint [52]
0
0
at 12 months, or at the time of re-intervention
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Secondary outcome [53]
0
0
Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 3.4) of the Target Lesion
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Assessment method [53]
0
0
Query!
Timepoint [53]
0
0
At 12 months, or at the time of re-intervention
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Secondary outcome [54]
0
0
150mm DEB ITT Cohort - MAEs
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Assessment method [54]
0
0
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days.
Query!
Timepoint [54]
0
0
30 days
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Secondary outcome [55]
0
0
150mm DEB ITT Cohort - MAEs
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Assessment method [55]
0
0
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 6 months.
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Timepoint [55]
0
0
6 months
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Secondary outcome [56]
0
0
150mm DEB ITT Cohort - MAEs
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Assessment method [56]
0
0
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 12 months.
Query!
Timepoint [56]
0
0
12 months
Query!
Secondary outcome [57]
0
0
150mm DEB ITT Cohort - MAEs
Query!
Assessment method [57]
0
0
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 24 months.
Query!
Timepoint [57]
0
0
24 months
Query!
Secondary outcome [58]
0
0
150mm DEB ITT Cohort - MAEs
Query!
Assessment method [58]
0
0
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 36 months.
Query!
Timepoint [58]
0
0
36 months
Query!
Secondary outcome [59]
0
0
150mm DEB ITT Cohort - MAEs
Query!
Assessment method [59]
0
0
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 48 months.
Query!
Timepoint [59]
0
0
48 months
Query!
Secondary outcome [60]
0
0
150mm DEB ITT Cohort - MAEs
Query!
Assessment method [60]
0
0
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 60 months.
Query!
Timepoint [60]
0
0
60 months
Query!
Secondary outcome [61]
0
0
150mm DEB ITT Cohort - Clinically-driven TLR
Query!
Assessment method [61]
0
0
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Query!
Timepoint [61]
0
0
30 days
Query!
Secondary outcome [62]
0
0
150mm DEB ITT Cohort - Clinically-driven TLR
Query!
Assessment method [62]
0
0
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Query!
Timepoint [62]
0
0
6 months
Query!
Secondary outcome [63]
0
0
150mm DEB ITT Cohort - Clinically-driven TLR
Query!
Assessment method [63]
0
0
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Query!
Timepoint [63]
0
0
24 months
Query!
Secondary outcome [64]
0
0
150mm DEB ITT Cohort - Clinically-driven TLR
Query!
Assessment method [64]
0
0
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Query!
Timepoint [64]
0
0
36 months
Query!
Secondary outcome [65]
0
0
150mm DEB ITT Cohort - Clinically-driven TLR
Query!
Assessment method [65]
0
0
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Query!
Timepoint [65]
0
0
48 months
Query!
Secondary outcome [66]
0
0
150mm DEB ITT Cohort - Clinically-driven TLR
Query!
Assessment method [66]
0
0
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Query!
Timepoint [66]
0
0
60 months
Query!
Secondary outcome [67]
0
0
150mm DEB ITT Cohort - TLR
Query!
Assessment method [67]
0
0
Any Target lesion revascularisation
Query!
Timepoint [67]
0
0
6 Months
Query!
Secondary outcome [68]
0
0
150mm DEB ITT Cohort - TLR
Query!
Assessment method [68]
0
0
Any Target lesion revascularisation
Query!
Timepoint [68]
0
0
12 Months
Query!
Secondary outcome [69]
0
0
150mm DEB ITT Cohort - TLR
Query!
Assessment method [69]
0
0
Any Target lesion revascularisation
Query!
Timepoint [69]
0
0
24 Months
Query!
Secondary outcome [70]
0
0
150mm DEB ITT Cohort - TLR
Query!
Assessment method [70]
0
0
Any Target lesion revascularisation
Query!
Timepoint [70]
0
0
36 Months
Query!
Secondary outcome [71]
0
0
150mm DEB ITT Cohort - TLR
Query!
Assessment method [71]
0
0
Any Target lesion revascularisation
Query!
Timepoint [71]
0
0
48 Months
Query!
Secondary outcome [72]
0
0
150mm DEB ITT Cohort - TLR
Query!
Assessment method [72]
0
0
Any Target lesion revascularisation
Query!
Timepoint [72]
0
0
60 Months
Query!
Secondary outcome [73]
0
0
150mm DEB ITT Cohort - TVR
Query!
Assessment method [73]
0
0
Any Target lesion revascularisation
Query!
Timepoint [73]
0
0
6 Months
Query!
Secondary outcome [74]
0
0
150mm DEB ITT Cohort - TVR
Query!
Assessment method [74]
0
0
Any Target lesion revascularisation
Query!
Timepoint [74]
0
0
12 Months
Query!
Secondary outcome [75]
0
0
150mm DEB ITT Cohort - TVR
Query!
Assessment method [75]
0
0
Any Target lesion revascularisation
Query!
Timepoint [75]
0
0
24 Months
Query!
Secondary outcome [76]
0
0
150mm DEB ITT Cohort - TVR
Query!
Assessment method [76]
0
0
Any Target lesion revascularisation
Query!
Timepoint [76]
0
0
36 Months
Query!
Secondary outcome [77]
0
0
150mm DEB ITT Cohort - TVR
Query!
Assessment method [77]
0
0
Any Target lesion revascularisation
Query!
Timepoint [77]
0
0
48 Months
Query!
Secondary outcome [78]
0
0
150mm DEB ITT Cohort - TVR
Query!
Assessment method [78]
0
0
Any Target lesion revascularisation
Query!
Timepoint [78]
0
0
60 Months
Query!
Secondary outcome [79]
0
0
150mm DEB ITT Cohort - Time to First Clinically-driven TLR (Days)
Query!
Assessment method [79]
0
0
Query!
Timepoint [79]
0
0
60 months
Query!
Secondary outcome [80]
0
0
150mm DEB ITT Cohort - Time to All-cause Mortality Through 60 Months Post-index Procedure.
Query!
Assessment method [80]
0
0
All-cause mortality is reported by using the survival estimate of all-cause mortality through 60 months
Query!
Timepoint [80]
0
0
60 months
Query!
Secondary outcome [81]
0
0
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Query!
Assessment method [81]
0
0
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Query!
Timepoint [81]
0
0
6 months.
Query!
Secondary outcome [82]
0
0
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Query!
Assessment method [82]
0
0
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Query!
Timepoint [82]
0
0
12 months.
Query!
Secondary outcome [83]
0
0
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Query!
Assessment method [83]
0
0
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Query!
Timepoint [83]
0
0
24 months
Query!
Secondary outcome [84]
0
0
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Query!
Assessment method [84]
0
0
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Query!
Timepoint [84]
0
0
36 months
Query!
Secondary outcome [85]
0
0
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Query!
Assessment method [85]
0
0
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Query!
Timepoint [85]
0
0
6 Months
Query!
Secondary outcome [86]
0
0
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Query!
Assessment method [86]
0
0
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Query!
Timepoint [86]
0
0
12 Months
Query!
Secondary outcome [87]
0
0
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Query!
Assessment method [87]
0
0
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Query!
Timepoint [87]
0
0
24 Months
Query!
Secondary outcome [88]
0
0
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Query!
Assessment method [88]
0
0
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Query!
Timepoint [88]
0
0
36 Months
Query!
Secondary outcome [89]
0
0
150mm DEB ITT Cohort - Immediate Hemodynamic Improvement at Post-index Procedure
Query!
Assessment method [89]
0
0
Immediate hemodynamic improvement is defined as an ABI improvement of = 0.1 or to an ABI = 0.9
Query!
Timepoint [89]
0
0
Post procedure
Query!
Secondary outcome [90]
0
0
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Query!
Assessment method [90]
0
0
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with = 0.1 as compared to baseline values or to an ABI = 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Query!
Timepoint [90]
0
0
6 Months
Query!
Secondary outcome [91]
0
0
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Query!
Assessment method [91]
0
0
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with = 0.1 as compared to baseline values or to an ABI = 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Query!
Timepoint [91]
0
0
12 Months
Query!
Secondary outcome [92]
0
0
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Query!
Assessment method [92]
0
0
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with = 0.1 as compared to baseline values or to an ABI = 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Query!
Timepoint [92]
0
0
24 Months
Query!
Secondary outcome [93]
0
0
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Query!
Assessment method [93]
0
0
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with = 0.1 as compared to baseline values or to an ABI = 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Query!
Timepoint [93]
0
0
36 Months
Query!
Secondary outcome [94]
0
0
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Query!
Assessment method [94]
0
0
Query!
Timepoint [94]
0
0
6 Months
Query!
Secondary outcome [95]
0
0
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Query!
Assessment method [95]
0
0
Query!
Timepoint [95]
0
0
12 Months
Query!
Secondary outcome [96]
0
0
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Query!
Assessment method [96]
0
0
Query!
Timepoint [96]
0
0
24 Months
Query!
Secondary outcome [97]
0
0
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Query!
Assessment method [97]
0
0
Query!
Timepoint [97]
0
0
36 Months
Query!
Secondary outcome [98]
0
0
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
Query!
Assessment method [98]
0
0
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Query!
Timepoint [98]
0
0
6 Months
Query!
Secondary outcome [99]
0
0
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
Query!
Assessment method [99]
0
0
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Query!
Timepoint [99]
0
0
12 Months
Query!
Secondary outcome [100]
0
0
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
Query!
Assessment method [100]
0
0
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Query!
Timepoint [100]
0
0
24 Months
Query!
Secondary outcome [101]
0
0
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
Query!
Assessment method [101]
0
0
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Query!
Timepoint [101]
0
0
36 Months
Query!
Secondary outcome [102]
0
0
150mm DEB ITT Cohort - Device Success
Query!
Assessment method [102]
0
0
Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)
Query!
Timepoint [102]
0
0
Index-procedure
Query!
Secondary outcome [103]
0
0
150mm DEB ITT Cohort - Procedural Success
Query!
Assessment method [103]
0
0
Procedural Success is defined as residual stenosis of = 50% (non-stented subjects) or = 30% (stented subjects) by visual estimate
Query!
Timepoint [103]
0
0
at procedure
Query!
Secondary outcome [104]
0
0
150mm DEB ITT Cohort - Clinical Success
Query!
Assessment method [104]
0
0
Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge
Query!
Timepoint [104]
0
0
prior to discharge
Query!
Secondary outcome [105]
0
0
Clinical Cohort ITT - All-cause Mortality
Query!
Assessment method [105]
0
0
Query!
Timepoint [105]
0
0
30 days
Query!
Secondary outcome [106]
0
0
Clinical Cohort ITT - All-cause Mortality
Query!
Assessment method [106]
0
0
Query!
Timepoint [106]
0
0
6 Months
Query!
Secondary outcome [107]
0
0
Clinical Cohort ITT - All-cause Mortality
Query!
Assessment method [107]
0
0
Query!
Timepoint [107]
0
0
12 Months
Query!
Secondary outcome [108]
0
0
Clinical Cohort ITT - All-cause Mortality
Query!
Assessment method [108]
0
0
Query!
Timepoint [108]
0
0
24 Months
Query!
Secondary outcome [109]
0
0
Clinical Cohort ITT - All-cause Mortality
Query!
Assessment method [109]
0
0
Query!
Timepoint [109]
0
0
36 Months
Query!
Secondary outcome [110]
0
0
Clinical Cohort ITT - All-cause Mortality
Query!
Assessment method [110]
0
0
Query!
Timepoint [110]
0
0
48 Months
Query!
Secondary outcome [111]
0
0
Clinical Cohort ITT - All-cause Mortality
Query!
Assessment method [111]
0
0
The difference in death count calculation between the compliance table (participant flow: 253 deaths) and the event table (244 deaths) is explained as follow:
1. Calendar days (365/year) is used for compliance table whereas 360-day annual cutoff is used for event rate calculation
2. Compliance table used visit window as specified by protocol (60 days for 5-year follow-up) whereas, not window is used for event rate calculation
3. Nine patients died between 1801 and 1885 (1825 + 60) and were therefore not included in the 5-year death rate summary but were included in the compliance summary for patients that died through the upper window of the 60 month visit.
4. The denominator of 1215 for 1800-day event rate includes those who had an event within 1800 days and those who did not have any event but had at least 1740 days of follow-up (1740 is the low bound of the 60-day visit window from the target day of 1800)
Query!
Timepoint [111]
0
0
60 Months
Query!
Secondary outcome [112]
0
0
Clinical Cohort ITT - Clinically-driven TVR
Query!
Assessment method [112]
0
0
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Query!
Timepoint [112]
0
0
30 days
Query!
Secondary outcome [113]
0
0
Clinical Cohort ITT - Clinically-driven TVR
Query!
Assessment method [113]
0
0
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Query!
Timepoint [113]
0
0
6 Months
Query!
Secondary outcome [114]
0
0
Clinical Cohort ITT - Clinically-driven TVR
Query!
Assessment method [114]
0
0
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Query!
Timepoint [114]
0
0
12 Months
Query!
Secondary outcome [115]
0
0
Clinical Clinical Cohort ITT - Clinically-driven TVR
Query!
Assessment method [115]
0
0
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Query!
Timepoint [115]
0
0
24 Months
Query!
Secondary outcome [116]
0
0
Clinical Cohort ITT - Clinically-driven TVR
Query!
Assessment method [116]
0
0
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Query!
Timepoint [116]
0
0
36 Months
Query!
Secondary outcome [117]
0
0
Clinical Cohort ITT - Clinically-driven TVR
Query!
Assessment method [117]
0
0
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Query!
Timepoint [117]
0
0
48 Months
Query!
Secondary outcome [118]
0
0
Clinical Cohort ITT - Clinically-driven TVR
Query!
Assessment method [118]
0
0
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Query!
Timepoint [118]
0
0
60 Months
Query!
Secondary outcome [119]
0
0
Clinical Cohort ITT - Major Target Limb Amputation
Query!
Assessment method [119]
0
0
Query!
Timepoint [119]
0
0
30 days
Query!
Secondary outcome [120]
0
0
Clinical Cohort ITT - Major Target Limb Amputation
Query!
Assessment method [120]
0
0
Query!
Timepoint [120]
0
0
6 Months
Query!
Secondary outcome [121]
0
0
Clinical Cohort ITT - Major Target Limb Amputation
Query!
Assessment method [121]
0
0
Query!
Timepoint [121]
0
0
12 Months
Query!
Secondary outcome [122]
0
0
Clinical Cohort ITT - Major Target Limb Amputation
Query!
Assessment method [122]
0
0
Query!
Timepoint [122]
0
0
24 Months
Query!
Secondary outcome [123]
0
0
Clinical Cohort ITT - Major Target Limb Amputation
Query!
Assessment method [123]
0
0
Query!
Timepoint [123]
0
0
36 Months
Query!
Secondary outcome [124]
0
0
Clinical Cohort ITT - Major Target Limb Amputation
Query!
Assessment method [124]
0
0
Query!
Timepoint [124]
0
0
48 Months
Query!
Secondary outcome [125]
0
0
Clinical Cohort ITT - Major Target Limb Amputation
Query!
Assessment method [125]
0
0
Query!
Timepoint [125]
0
0
60 Months
Query!
Secondary outcome [126]
0
0
150mm DEB ITT Cohort - All-cause Mortality
Query!
Assessment method [126]
0
0
Query!
Timepoint [126]
0
0
30 days
Query!
Secondary outcome [127]
0
0
150mm DEB ITT Cohort - All-cause Mortality
Query!
Assessment method [127]
0
0
Query!
Timepoint [127]
0
0
6 Months
Query!
Secondary outcome [128]
0
0
150mm DEB ITT Cohort - All-cause Mortality
Query!
Assessment method [128]
0
0
Query!
Timepoint [128]
0
0
12 Months
Query!
Secondary outcome [129]
0
0
150mm DEB ITT Cohort - All-cause Mortality
Query!
Assessment method [129]
0
0
Query!
Timepoint [129]
0
0
24 Months
Query!
Secondary outcome [130]
0
0
150mm DEB ITT Cohort - All-cause Mortality
Query!
Assessment method [130]
0
0
Query!
Timepoint [130]
0
0
36 Months
Query!
Secondary outcome [131]
0
0
150mm DEB ITT Cohort - All-cause Mortality
Query!
Assessment method [131]
0
0
Query!
Timepoint [131]
0
0
48 Months
Query!
Secondary outcome [132]
0
0
150mm DEB ITT Cohort - All-cause Mortality
Query!
Assessment method [132]
0
0
Query!
Timepoint [132]
0
0
60 Months
Query!
Secondary outcome [133]
0
0
150mm DEB ITT Cohort - Clinically-driven TVR
Query!
Assessment method [133]
0
0
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Query!
Timepoint [133]
0
0
30 days
Query!
Secondary outcome [134]
0
0
150mm DEB ITT Cohort - Clinically-driven TVR
Query!
Assessment method [134]
0
0
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Query!
Timepoint [134]
0
0
6 Months
Query!
Secondary outcome [135]
0
0
150mm DEB ITT Cohort - Clinically-driven TVR
Query!
Assessment method [135]
0
0
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Query!
Timepoint [135]
0
0
12 Months
Query!
Secondary outcome [136]
0
0
150mm DEB ITT Cohort - Clinically-driven TVR
Query!
Assessment method [136]
0
0
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Query!
Timepoint [136]
0
0
24 Months
Query!
Secondary outcome [137]
0
0
150mm DEB ITT Cohort - Clinically-driven TVR
Query!
Assessment method [137]
0
0
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Query!
Timepoint [137]
0
0
36 Months
Query!
Secondary outcome [138]
0
0
150mm DEB ITT Cohort - Clinically-driven TVR
Query!
Assessment method [138]
0
0
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Query!
Timepoint [138]
0
0
48 Months
Query!
Secondary outcome [139]
0
0
150mm DEB ITT Cohort - Clinically-driven TVR
Query!
Assessment method [139]
0
0
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Query!
Timepoint [139]
0
0
60 Months
Query!
Secondary outcome [140]
0
0
150mm DEB ITT Cohort - Major Target Limb Amputation
Query!
Assessment method [140]
0
0
Query!
Timepoint [140]
0
0
30 days
Query!
Secondary outcome [141]
0
0
150mm DEB ITT Cohort - Major Target Limb Amputation
Query!
Assessment method [141]
0
0
Query!
Timepoint [141]
0
0
6 Months
Query!
Secondary outcome [142]
0
0
150mm DEB ITT Cohort - Major Target Limb Amputation
Query!
Assessment method [142]
0
0
Query!
Timepoint [142]
0
0
12 Months
Query!
Secondary outcome [143]
0
0
150mm DEB ITT Cohort - Major Target Limb Amputation
Query!
Assessment method [143]
0
0
Query!
Timepoint [143]
0
0
24 Months
Query!
Secondary outcome [144]
0
0
150mm DEB ITT Cohort - Major Target Limb Amputation
Query!
Assessment method [144]
0
0
Query!
Timepoint [144]
0
0
36 Months
Query!
Secondary outcome [145]
0
0
150mm DEB ITT Cohort - Major Target Limb Amputation
Query!
Assessment method [145]
0
0
Query!
Timepoint [145]
0
0
48 Months
Query!
Secondary outcome [146]
0
0
150mm DEB ITT Cohort - Major Target Limb Amputation
Query!
Assessment method [146]
0
0
Query!
Timepoint [146]
0
0
60 Months
Query!
Eligibility
Key inclusion criteria
General inclusion Criteria:
* Age = 18 years or minimum age as required by local regulations.
* Subject with documented diagnosis of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and/or popliteal artery (PA) (including P1, P2, P3) classified as Rutherford class 2-3-4.
* Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis) within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days.
General exclusion Criteria:
* High probability of non-adherence to Clinical Investigation Protocol follow-up requirements.
* Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations).
* Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/05/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
17/01/2020
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Sample size
Target
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Accrual to date
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Final
1535
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Sydney
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Recruitment postcode(s) [1]
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NSW 2050 - Sydney
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Recruitment outside Australia
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Argentina
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Buenos Aires
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Argentina
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Bueos Aires
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Austria
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Graz
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Austria
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Mödling
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Belgium
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Aalst
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Belgium
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Bonheiden
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Belgium
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Dendermonde
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Belgium
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Edegem
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Belgium
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Genk
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Belgium
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Gent
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Belgium
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Tienen
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Canada
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Sherbrooke
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Canada
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Toronto
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Colombia
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Medellin
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Colombia
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Neiva
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Czechia
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Hradec Kralove
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Egypt
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Cairo
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Finland
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Helsinki
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France
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Bordeaux Cedex
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France
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Strasbourg
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Germany
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Bad Krozingen
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Germany
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Duesseldorf
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Germany
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Düsseldorf
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Germany
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Heidelberg
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Germany
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Leipzig
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Germany
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Münster
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Germany
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Rosenheim
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Germany
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Tübingen
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Greece
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Patra
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Hungary
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Budapest
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Hungary
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Kecskemét
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Israel
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Haifa
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Israel
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Petach Tikva
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Italy
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Catania
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Italy
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Palermo
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Italy
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Rome
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon
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Lithuania
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Kaunas
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Netherlands
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's Hertogenbosch
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Netherlands
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Arnhem
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Netherlands
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Eindhoven
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Netherlands
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Nieuwegein
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Netherlands
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Utrecht
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Poland
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Katowice
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Poland
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Szczecin
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Portugal
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Lisbon
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Russian Federation
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Moscow
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Singapore
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Singapore
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Slovakia
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Banská Bystrica
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Slovenia
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Maribor
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Sweden
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Solna
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Switzerland
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Bern
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Switzerland
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Fribourg
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Switzerland
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Luzern
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United Kingdom
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Manchester
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Country [59]
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United Kingdom
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State/province [59]
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Medtronic Endovascular
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population.
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Trial website
https://clinicaltrials.gov/study/NCT01609296
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Trial related presentations / publications
Krishnan P, Farhan S, Schneider P, Kamran H, Iida O, Brodmann M, Micari A, Sachar R, Urasawa K, Scheinert D, Ando K, Tarricone A, Doros G, Tepe G, Yokoi H, Laird J, Zeller T. Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention. J Am Coll Cardiol. 2022 Sep 27;80(13):1241-1250. doi: 10.1016/j.jacc.2022.06.043. Brodmann M, Lansink W, Guetl K, Micari A, Menk J, Zeller T. Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study. Cardiovasc Intervent Radiol. 2022 Sep;45(9):1276-1287. doi: 10.1007/s00270-022-03214-y. Epub 2022 Jul 21. Zeller T, Brodmann M, Ansel GM, Scheinert D, Choi D, Tepe G, Menk J, Micari A. Paclitaxel-coated balloons for femoropopliteal peripheral arterial disease: final five-year results of the IN.PACT Global Study. EuroIntervention. 2022 Dec 2;18(11):e940-e948. doi: 10.4244/EIJ-D-21-01098. Torsello G, Stavroulakis K, Brodmann M, Micari A, Tepe G, Veroux P, Benko A, Choi D, Vermassen FEG, Jaff MR, Guo J, Dobranszki R, Zeller T; IN.PACT Global Investigators. Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort. J Endovasc Ther. 2020 Oct;27(5):693-705. doi: 10.1177/1526602820931477. Epub 2020 Jun 25. Shishehbor MH, Schneider PA, Zeller T, Razavi MK, Laird JR, Wang H, Tieche C, Parikh SA, Iida O, Jaff MR. Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts. J Vasc Surg. 2019 Oct;70(4):1177-1191.e9. doi: 10.1016/j.jvs.2019.02.030. Reijnen MMPJ, van Wijck I, Zeller T, Micari A, Veroux P, Keirse K, Lee SW, Li P, Voulgaraki D, Holewijn S. Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study. J Endovasc Ther. 2019 Jun;26(3):305-315. doi: 10.1177/1526602819839044. Epub 2019 Apr 1. Tepe G, Micari A, Keirse K, Zeller T, Scheinert D, Li P, Schmahl R, Jaff MR; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The Chronic Total Occlusion Cohort in the IN.PACT Global Study. JACC Cardiovasc Interv. 2019 Mar 11;12(5):484-493. doi: 10.1016/j.jcin.2018.12.004. Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M, Micari A, Shishehbor MH, Tepe G, Zeller T. Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon. J Am Coll Cardiol. 2019 May 28;73(20):2550-2563. doi: 10.1016/j.jacc.2019.01.013. Epub 2019 Jan 25. Erratum In: J Am Coll Cardiol. 2019 May 28;73(20):2643-2645. doi: 10.1016/j.jacc.2019.02.029. Zeller T, Brodmann M, Micari A, Keirse K, Peeters P, Tepe G, Scheinert D, Jaff MR, Rocha-Singh KJ, Li P, Schmahl R, Ansel GM; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain. Circ Cardiovasc Interv. 2019 Jan;12(1):e007730. doi: 10.1161/CIRCINTERVENTIONS.118.007730. No abstract available. Banerjee S, Khalili H. Drug-Coated Balloon for Long Femoropopliteal Lesions. Circ Cardiovasc Interv. 2018 Oct;11(10):e007084. doi: 10.1161/CIRCINTERVENTIONS.118.007084. No abstract available. Scheinert D, Micari A, Brodmann M, Tepe G, Peeters P, Jaff MR, Wang H, Schmahl R, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease. Circ Cardiovasc Interv. 2018 Oct;11(10):e005654. doi: 10.1161/CIRCINTERVENTIONS.117.005654. Ansel GM, Brodmann M, Keirse K, Micari A, Jaff MR, Rocha-Singh K, Fernandez EJ, Wang H, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From the IN.PACT Global Study. J Endovasc Ther. 2018 Dec;25(6):673-682. doi: 10.1177/1526602818803119. Epub 2018 Oct 3. Micari A, Brodmann M, Keirse K, Peeters P, Tepe G, Frost M, Wang H, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study. JACC Cardiovasc Interv. 2018 May 28;11(10):945-953. doi: 10.1016/j.jcin.2018.02.019.
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Public notes
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Contacts
Principal investigator
Name
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Gunnar Tepe, MD
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Address
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Klinikum Rosenheim
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Phone
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Fax
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01609296