Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01609296
Registration number
NCT01609296
Ethics application status
Date submitted
24/05/2012
Date registered
31/05/2012
Date last updated
25/03/2021
Titles & IDs
Public title
IN.PACT Global Clinical Study
Query!
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.
Query!
Secondary ID [1]
0
0
10048613
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Clinical Cohort ITT - Primary Effectiveness Endpoint
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
12 months
Query!
Primary outcome [2]
0
0
Clinical Cohort ITT - Primary Safety Endpoint
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
12 months
Query!
Primary outcome [3]
0
0
Imaging Cohort ITT - Primary Effectiveness Endpoint
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
12 months
Query!
Primary outcome [4]
0
0
150mm DEB ITT Cohort - Primary Effectiveness Endpoint
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
12 months
Query!
Secondary outcome [1]
0
0
Clinical Cohort ITT - MAEs
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
12 months
Query!
Secondary outcome [2]
0
0
Clinical Cohort ITT - TLR
Query!
Assessment method [2]
0
0
Any Target lesion revascularisation
Query!
Timepoint [2]
0
0
12 months
Query!
Secondary outcome [3]
0
0
Clinical Cohort ITT - TVR
Query!
Assessment method [3]
0
0
Any Target vessel revascularisation
Query!
Timepoint [3]
0
0
12 months.
Query!
Secondary outcome [4]
0
0
Clinical Cohort ITT - Device Success
Query!
Assessment method [4]
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 [4]
0
0
Index-procedure
Query!
Secondary outcome [5]
0
0
Clinical Cohort ITT - Clinical Success
Query!
Assessment method [5]
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 [5]
0
0
prior to discharge
Query!
Secondary outcome [6]
0
0
Clinical Cohort ITT - MAEs
Query!
Assessment method [6]
0
0
MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
Query!
Timepoint [6]
0
0
60 months
Query!
Secondary outcome [7]
0
0
Clinical Cohort ITT - Clinically-driven TLR
Query!
Assessment method [7]
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 [7]
0
0
60 months
Query!
Secondary outcome [8]
0
0
Clinical Cohort ITT - TVR
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
60 months
Query!
Secondary outcome [9]
0
0
Clinical Cohort ITT - TLR
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
60 months
Query!
Secondary outcome [10]
0
0
Clinical Cohort ITT - Time to First Clinically-driven TLR (Days)
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
60 months
Query!
Secondary outcome [11]
0
0
Clinical Cohort ITT - MAEs
Query!
Assessment method [11]
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 [11]
0
0
30 days
Query!
Secondary outcome [12]
0
0
Clinical Cohort ITT - MAEs
Query!
Assessment method [12]
0
0
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site
Query!
Timepoint [12]
0
0
6 Months
Query!
Secondary outcome [13]
0
0
Clinical Cohort ITT - MAEs
Query!
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.
Query!
Timepoint [13]
0
0
24 Months
Query!
Secondary outcome [14]
0
0
Clinical Cohort ITT - MAEs
Query!
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.
Query!
Timepoint [14]
0
0
36 Months
Query!
Secondary outcome [15]
0
0
Clinical Cohort ITT - MAEs
Query!
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.
Query!
Timepoint [15]
0
0
48 Months
Query!
Secondary outcome [16]
0
0
Clinical Cohort ITT - Clinically-driven TLR
Query!
Assessment method [16]
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 [16]
0
0
30 days
Query!
Secondary outcome [17]
0
0
Clinical Cohort ITT - Clinically-driven TLR
Query!
Assessment method [17]
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 [17]
0
0
6 Months
Query!
Secondary outcome [18]
0
0
Clinical Cohort ITT - Clinically-driven TLR
Query!
Assessment method [18]
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 [18]
0
0
24 Months
Query!
Secondary outcome [19]
0
0
Clinical Cohort ITT - Clinically-driven TLR
Query!
Assessment method [19]
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 [19]
0
0
36 Months
Query!
Secondary outcome [20]
0
0
Clinical Cohort ITT - Clinically-driven TLR
Query!
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.
Query!
Timepoint [20]
0
0
48 Months
Query!
Secondary outcome [21]
0
0
Clinical Cohort ITT - TLR
Query!
Assessment method [21]
0
0
Any Target lesion revascularisation
Query!
Timepoint [21]
0
0
6 Months
Query!
Secondary outcome [22]
0
0
Clinical Cohort ITT - TLR
Query!
Assessment method [22]
0
0
Any Target lesion revascularisation
Query!
Timepoint [22]
0
0
24 Months
Query!
Secondary outcome [23]
0
0
Clinical Cohort ITT - TLR
Query!
Assessment method [23]
0
0
Any Target lesion revascularisation
Query!
Timepoint [23]
0
0
36 Months
Query!
Secondary outcome [24]
0
0
Clinical Cohort ITT - TLR
Query!
Assessment method [24]
0
0
Any Target lesion revascularisation
Query!
Timepoint [24]
0
0
48 Months
Query!
Secondary outcome [25]
0
0
Clinical Cohort ITT - TVR
Query!
Assessment method [25]
0
0
Any Target lesion revascularisation
Query!
Timepoint [25]
0
0
24 Months
Query!
Secondary outcome [26]
0
0
Clinical Cohort ITT - TVR
Query!
Assessment method [26]
0
0
Any Target lesion revascularisation
Query!
Timepoint [26]
0
0
36 Months
Query!
Secondary outcome [27]
0
0
Clinical Cohort ITT - TVR
Query!
Assessment method [27]
0
0
Any Target lesion revascularisation
Query!
Timepoint [27]
0
0
48 Months
Query!
Secondary outcome [28]
0
0
Clinical Cohort ITT - TVR
Query!
Assessment method [28]
0
0
Any Target lesion revascularisation
Query!
Timepoint [28]
0
0
6 Months
Query!
Secondary outcome [29]
0
0
Clinical Cohort ITT - Time to All-cause Mortality Through 60 Months Post-index Procedure.
Query!
Assessment method [29]
0
0
All-cause mortality is reported by using the survival estimate of all cause mortality through 60 months
Query!
Timepoint [29]
0
0
60 months
Query!
Secondary outcome [30]
0
0
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Query!
Assessment method [30]
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 [30]
0
0
6 Months
Query!
Secondary outcome [31]
0
0
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Query!
Assessment method [31]
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 [31]
0
0
12 Months
Query!
Secondary outcome [32]
0
0
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Query!
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
Query!
Timepoint [32]
0
0
24 Months
Query!
Secondary outcome [33]
0
0
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Query!
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
Query!
Timepoint [33]
0
0
36 Months
Query!
Secondary outcome [34]
0
0
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Query!
Assessment method [34]
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 [34]
0
0
6 Months
Query!
Secondary outcome [35]
0
0
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Query!
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.
Query!
Timepoint [35]
0
0
12 Months
Query!
Secondary outcome [36]
0
0
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Query!
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.
Query!
Timepoint [36]
0
0
24 Months
Query!
Secondary outcome [37]
0
0
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Query!
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.
Query!
Timepoint [37]
0
0
36 Months
Query!
Secondary outcome [38]
0
0
Clinical Cohort ITT - Immediate Hemodynamic Improvement at Post-index Procedure
Query!
Assessment method [38]
0
0
Immediate hemodynamic improvement is defined as an ABI improvement of = 0.1 or to an ABI = 0.9
Query!
Timepoint [38]
0
0
Post procedure
Query!
Secondary outcome [39]
0
0
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Query!
Assessment method [39]
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 [39]
0
0
6 Months
Query!
Secondary outcome [40]
0
0
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Query!
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.
Query!
Timepoint [40]
0
0
12 Months
Query!
Secondary outcome [41]
0
0
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Query!
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.
Query!
Timepoint [41]
0
0
24 Months
Query!
Secondary outcome [42]
0
0
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Query!
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.
Query!
Timepoint [42]
0
0
36 Months
Query!
Secondary outcome [43]
0
0
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Query!
Assessment method [43]
0
0
Query!
Timepoint [43]
0
0
6 Months
Query!
Secondary outcome [44]
0
0
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Query!
Assessment method [44]
0
0
Query!
Timepoint [44]
0
0
12 Months
Query!
Secondary outcome [45]
0
0
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Query!
Assessment method [45]
0
0
Query!
Timepoint [45]
0
0
24 Months
Query!
Secondary outcome [46]
0
0
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Query!
Assessment method [46]
0
0
Query!
Timepoint [46]
0
0
36 Months
Query!
Secondary outcome [47]
0
0
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
Query!
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.
Query!
Timepoint [47]
0
0
6 Months
Query!
Secondary outcome [48]
0
0
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
Query!
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.
Query!
Timepoint [48]
0
0
12 Months
Query!
Secondary outcome [49]
0
0
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
Query!
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.
Query!
Timepoint [49]
0
0
24 Months
Query!
Secondary outcome [50]
0
0
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
Query!
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.
Query!
Timepoint [50]
0
0
36 Months
Query!
Secondary outcome [51]
0
0
Clinical Cohort ITT - Procedural Success
Query!
Assessment method [51]
0
0
Procedural Success is defined as residual stenosis of = 50% (non-stented subjects) or = 30% (stented subjects) by visual estimate
Query!
Timepoint [51]
0
0
at procedure
Query!
Secondary outcome [52]
0
0
Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 2.0) of the Target Lesion
Query!
Assessment method [52]
0
0
Query!
Timepoint [52]
0
0
at 12 months, or at the time of re-intervention
Query!
Secondary outcome [53]
0
0
Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 3.4) of the Target Lesion
Query!
Assessment method [53]
0
0
Query!
Timepoint [53]
0
0
At 12 months, or at the time of re-intervention
Query!
Secondary outcome [54]
0
0
150mm DEB ITT Cohort - MAEs
Query!
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
Query!
Secondary outcome [55]
0
0
150mm DEB ITT Cohort - MAEs
Query!
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.
Query!
Timepoint [55]
0
0
6 months
Query!
Secondary outcome [56]
0
0
150mm DEB ITT Cohort - MAEs
Query!
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:
Calendar days (365/year) is used for compliance table whereas 360-day annual cutoff is used for event rate calculation
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
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.
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
N/A
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
Not Applicable
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
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1535
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Royal Prince Alfred Hospital - Sydney
Query!
Recruitment postcode(s) [1]
0
0
NSW 2050 - Sydney
Query!
Recruitment outside Australia
Country [1]
0
0
Argentina
Query!
State/province [1]
0
0
Buenos Aires
Query!
Country [2]
0
0
Argentina
Query!
State/province [2]
0
0
Bueos Aires
Query!
Country [3]
0
0
Austria
Query!
State/province [3]
0
0
Graz
Query!
Country [4]
0
0
Austria
Query!
State/province [4]
0
0
Mödling
Query!
Country [5]
0
0
Belgium
Query!
State/province [5]
0
0
Aalst
Query!
Country [6]
0
0
Belgium
Query!
State/province [6]
0
0
Bonheiden
Query!
Country [7]
0
0
Belgium
Query!
State/province [7]
0
0
Dendermonde
Query!
Country [8]
0
0
Belgium
Query!
State/province [8]
0
0
Edegem
Query!
Country [9]
0
0
Belgium
Query!
State/province [9]
0
0
Genk
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
Gent
Query!
Country [11]
0
0
Belgium
Query!
State/province [11]
0
0
Tienen
Query!
Country [12]
0
0
Canada
Query!
State/province [12]
0
0
Sherbrooke
Query!
Country [13]
0
0
Canada
Query!
State/province [13]
0
0
Toronto
Query!
Country [14]
0
0
Colombia
Query!
State/province [14]
0
0
Medellin
Query!
Country [15]
0
0
Colombia
Query!
State/province [15]
0
0
Neiva
Query!
Country [16]
0
0
Czechia
Query!
State/province [16]
0
0
Hradec Kralove
Query!
Country [17]
0
0
Egypt
Query!
State/province [17]
0
0
Cairo
Query!
Country [18]
0
0
Finland
Query!
State/province [18]
0
0
Helsinki
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Bordeaux Cedex
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Strasbourg
Query!
Country [21]
0
0
Germany
Query!
State/province [21]
0
0
Bad Krozingen
Query!
Country [22]
0
0
Germany
Query!
State/province [22]
0
0
Duesseldorf
Query!
Country [23]
0
0
Germany
Query!
State/province [23]
0
0
Düsseldorf
Query!
Country [24]
0
0
Germany
Query!
State/province [24]
0
0
Heidelberg
Query!
Country [25]
0
0
Germany
Query!
State/province [25]
0
0
Leipzig
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Münster
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Rosenheim
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Tübingen
Query!
Country [29]
0
0
Greece
Query!
State/province [29]
0
0
Patra
Query!
Country [30]
0
0
Hungary
Query!
State/province [30]
0
0
Budapest
Query!
Country [31]
0
0
Hungary
Query!
State/province [31]
0
0
Kecskemét
Query!
Country [32]
0
0
Israel
Query!
State/province [32]
0
0
Haifa
Query!
Country [33]
0
0
Israel
Query!
State/province [33]
0
0
Petach Tikva
Query!
Country [34]
0
0
Italy
Query!
State/province [34]
0
0
Catania
Query!
Country [35]
0
0
Italy
Query!
State/province [35]
0
0
Palermo
Query!
Country [36]
0
0
Italy
Query!
State/province [36]
0
0
Rome
Query!
Country [37]
0
0
Korea, Republic of
Query!
State/province [37]
0
0
Seoul
Query!
Country [38]
0
0
Korea, Republic of
Query!
State/province [38]
0
0
Suwon
Query!
Country [39]
0
0
Lithuania
Query!
State/province [39]
0
0
Kaunas
Query!
Country [40]
0
0
Netherlands
Query!
State/province [40]
0
0
's Hertogenbosch
Query!
Country [41]
0
0
Netherlands
Query!
State/province [41]
0
0
Arnhem
Query!
Country [42]
0
0
Netherlands
Query!
State/province [42]
0
0
Eindhoven
Query!
Country [43]
0
0
Netherlands
Query!
State/province [43]
0
0
Nieuwegein
Query!
Country [44]
0
0
Netherlands
Query!
State/province [44]
0
0
Utrecht
Query!
Country [45]
0
0
Poland
Query!
State/province [45]
0
0
Katowice
Query!
Country [46]
0
0
Poland
Query!
State/province [46]
0
0
Szczecin
Query!
Country [47]
0
0
Portugal
Query!
State/province [47]
0
0
Lisbon
Query!
Country [48]
0
0
Russian Federation
Query!
State/province [48]
0
0
Moscow
Query!
Country [49]
0
0
Singapore
Query!
State/province [49]
0
0
Singapore
Query!
Country [50]
0
0
Slovakia
Query!
State/province [50]
0
0
Banská Bystrica
Query!
Country [51]
0
0
Slovakia
Query!
State/province [51]
0
0
Bratislava
Query!
Country [52]
0
0
Slovakia
Query!
State/province [52]
0
0
Kosice
Query!
Country [53]
0
0
Slovenia
Query!
State/province [53]
0
0
Maribor
Query!
Country [54]
0
0
Sweden
Query!
State/province [54]
0
0
Solna
Query!
Country [55]
0
0
Switzerland
Query!
State/province [55]
0
0
Bern
Query!
Country [56]
0
0
Switzerland
Query!
State/province [56]
0
0
Fribourg
Query!
Country [57]
0
0
Switzerland
Query!
State/province [57]
0
0
Luzern
Query!
Country [58]
0
0
United Kingdom
Query!
State/province [58]
0
0
Manchester
Query!
Country [59]
0
0
United Kingdom
Query!
State/province [59]
0
0
Sheffield
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Medtronic Endovascular
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01609296
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Gunnar Tepe, MD
Query!
Address
0
0
Klinikum Rosenheim
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01609296
Download to PDF