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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03241459
Registration number
NCT03241459
Ethics application status
Date submitted
1/08/2017
Date registered
7/08/2017
Date last updated
9/04/2024
Titles & IDs
Public title
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon
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Scientific title
Randomized & Controlled Noninferiority Trial to Evaluate Safety & Clinical Efficacy of SurVeil™ Drug-Coated Balloon (DCB) iN Treatment of Subjects With Stenotic Lesions of Femoropopliteal Artery Compared to Medtronic IN.PACT® Admiral® DCB
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Secondary ID [1]
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SUR17-001
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Universal Trial Number (UTN)
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Trial acronym
TRANSCEND
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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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Peripheral Vascular Disease
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Artery Disease, Peripheral
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Femoropopliteal Artery Occlusion
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Condition category
Condition code
Cardiovascular
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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 - Surmodics SurVeil DCB
Treatment: Devices - Medtronic IN.PACT Admiral DCB
Experimental: Surmodics SurVeil DCB - Surmodics SurVeil Drug-Coated Balloon is an investigational device coated with paclitaxel.
Active Comparator: Medtronic IN.PACT Admiral DCB - Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
Treatment: Devices: Surmodics SurVeil DCB
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
Treatment: Devices: Medtronic IN.PACT Admiral DCB
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
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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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Primary Lesion Patency Though 12 Months
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Assessment method [1]
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Composite of freedom from clinically-driven target lesion revascularization (TLR) and binary restenosis (restenosis defined as duplex ultrasound [DUS] peak systolic velocity ratio [PSVR] =2.4 or =50% stenosis as assessed by independent angiographic and DUS core labs) through 12 months post-index procedure.
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Timepoint [1]
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12 months
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Primary outcome [2]
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Safety Composite of Freedom From Death, Amputation, and Target Vessel Revascularization (TVR)
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Assessment method [2]
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Composite of freedom from device- and procedure-related death through 30 days post-index procedure and freedom from major target limb amputation (above the ankle) and clinically-driven TVR through 12 months post-index procedure.
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Timepoint [2]
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12 months
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Secondary outcome [1]
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Proportion of Participants With Device Success
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Assessment method [1]
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Defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure, and achievement of <50% residual stenosis of the target lesion (by core lab-assessed quantitative angiography [QA]) without flow-limiting arterial dissection (= 50% residual stenosis or dissection grade E or F) using only the study device.
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Timepoint [1]
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Day 0
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Secondary outcome [2]
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Proportion of Participants With Technical Success
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Assessment method [2]
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Defined as achievement of a final residual diameter stenosis of <50% (by core lab-assessed QA) without flow-limiting arterial dissection at the end of the procedure.
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Timepoint [2]
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Day 0
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Secondary outcome [3]
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Proportion of Participants With Procedure Success
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Assessment method [3]
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Defined as evidence of both acute technical success and absence of Peripheral Academic Research Consortium major adverse events (PARC MAEs; e.g., death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and or need for urgent/emergent vascular surgery) within 72 hours of the index procedure.
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Timepoint [3]
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72 hours
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Secondary outcome [4]
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Freedom From All-cause Death, Major Target Limb Amputation and TVR Through 30 Days
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Assessment method [4]
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Proportion of participation free of all-cause death, major target limb amputation and TVR through 30 days. All clinical endpoints adjudications by independent, blinded CEC.
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Timepoint [4]
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30 days
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Secondary outcome [5]
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Proportion of Participants With Primary Lesion Patency
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Assessment method [5]
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Primary patency through 24 months (only if both the primary safety and efficacy hypotheses of noninferiority are met).
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Timepoint [5]
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24 months
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Secondary outcome [6]
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Proportion of Participants With Target Vessel Patency
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Assessment method [6]
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Defined as freedom from clinically-driven target vessel revascularization (TVR) and binary restenosis (restenosis defined as DUS PSVR =2.4 or =50% stenosis as assessed by independent angiographic and DUS core labs) within 12 and 24 months.
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Timepoint [6]
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12 months, 24 months
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Secondary outcome [7]
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Proportion of Participants With Sustained Clinical Improvement
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Assessment method [7]
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Defined as freedom from major target limb amputation, TVR and worsening target limb Rutherford class, within 6, 12, and 24 months.
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Timepoint [7]
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6 months, 12 months, 24 months
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Secondary outcome [8]
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Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR)
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Assessment method [8]
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Includes participants experiencing a clinically-driven target lesion revascularization event as reported by sites and adjudicated by an independent CEC.
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Timepoint [8]
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6 months, 12 months, 24 months
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Secondary outcome [9]
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Proportion of Participants With a Historical Major Adverse Events (MAEs)
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Assessment method [9]
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MAEs defined as composite of all-cause death, clinically-driven TLR, major target limb amputation, or thrombosis at the target lesion, within 6, 12, 24 months.
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Timepoint [9]
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6 months, 12 months, 24 months
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Secondary outcome [10]
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Proportion of Participants With a Major Target Limb Amputation
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Assessment method [10]
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Major target limb amputation within 6, 12, 24 months as reported by site and adjudicated by CEC.
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Timepoint [10]
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6 months, 12 months, 24 months
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Secondary outcome [11]
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Proportion of Participants With a Thrombosis at the Target Lesion.
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Assessment method [11]
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Thrombosis at target lesion within 6, 12, 24 months as reported by the site and adjudicated by the CEC.
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Timepoint [11]
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6 months, 12 months, 24 months
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Secondary outcome [12]
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Change in Target Limb Rutherford Class
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Assessment method [12]
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Change in target limb Rutherford class from Baseline (BL) to 1, 6, 12, and 24 months.
Rutherford classification criteria categorize the severity of chronic limb ischemia based on a clinical description of symptoms and pre-defined objective criteria.
Possible scores range from 0 to 6 with scores defined as follows:
0 - Asymptomatic - no hemodynamically significant occlusive disease
- Mild claudication
- Moderate claudication
- Severe claudication
- Ischemic rest pain
- Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia
- Major tissue loss, extending above transmetatarsal) with all scores defined as follows:
Change = 1-Month scores - BL scores; 6-Month scores - BL scores; 12-Month scores - BL scores; 24-Month scores - BL scores
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Timepoint [12]
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Baseline, 1 month, 6 months, 12 months, and 24 months
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Secondary outcome [13]
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Change in Target Limb Peripheral Academic Research Consortium (PARC) Class
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Assessment method [13]
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Change in target limb PARC class from baseline to 1, 6, 12, and 24 months.
PARC definitions of clinical symptom classification were used to classify subject claudication at baseline and subsequent follow-up visits. PARC clinical symptom classification is used to capture information regarding lower extremity symptoms and broadly define functional limitations of patients with lower extremity peripheral artery disease (PAD).
Possible classifications include the following:
Asymptomatic Mild claudication/limb symptoms (no limitation in walking) Moderate claudication/limb symptoms (able to walk without stopping > 2 blocks or 200 meters or 4 minutes) Severe claudication/limb symptoms (only able to walk without stopping < 2 blocks or 200 meters or 4 minutes) Ischemic rest pain (pain in the distal limb at rest, felt to be due to limited arterial perfusion) Ischemic ulcers on distal leg Ischemic gangrene
Change = 1-Month scores - BL scores; 6-Month scores - BL scores; 12-Mon
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Timepoint [13]
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Screening, 1 month, 6 months, 12 months, and 24 months
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Secondary outcome [14]
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Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI)
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Assessment method [14]
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Decrease in target limb resting ABI or TBI =0.15 from baseline to 6, 12, and 24 months.
Ankle-brachial index (ABI) is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial artery.
Toe brachial index (TBI) is the ratio of SBP measured at the toe to that measured at the brachial artery.
if ABI could not be assessed, TBI could be used.
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Timepoint [14]
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Screening, 6 months, 12 months, and 24 months
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Secondary outcome [15]
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Change in Walking Impairment Questionnaire (WIQ)
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Assessment method [15]
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Walking Impairment Questionnaire is a validated tool that has 4 domains (Walking Impairment, Walking Distance, Walking Speed, and Stair Climbing), each scored as a percent ranging from 0 (representing the inability to perform any of the tasks) to 100 (representing no difficulty with any of the tasks). A positive change in a score indicates an improvement.
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Timepoint [15]
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Screening, 1 month, 12 months, and 24 months
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Secondary outcome [16]
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Change in 6-Minute Walk Test (6MWT)
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Assessment method [16]
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Change in 6MWT from baseline to 12 and 24 months.
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Timepoint [16]
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Screening, 12 months, and 24 months
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Secondary outcome [17]
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Change in Peripheral Artery Questionnaire (PAQ)
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Assessment method [17]
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The PAQ consists of 7 domains including physical function, stability, symptom, treatment satisfaction, quality of life, social limitation, and summary. Scores range from 0 to 100, with a positive change indicating an improvement.
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Timepoint [17]
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Screening, 1 month, 12 months, and 24 months
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Secondary outcome [18]
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Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR)
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Assessment method [18]
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Includes participants experiencing a clinically-driven target lesion revascularization event as reported by sites and adjudicated by an independent CEC.
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Timepoint [18]
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36 months, 48 months, 60 months
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Secondary outcome [19]
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Proportion of Participants With a Historical Major Adverse Events (MAEs)
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Assessment method [19]
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MAEs defined as composite of all-cause death, clinically-driven TLR, major target limb amputation, or thrombosis at the target lesion within 36, 48, and 60 months.
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Timepoint [19]
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36 months, 48 months, 60 months
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Secondary outcome [20]
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Proportion of Participants With a Major Target Limb Amputation
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Assessment method [20]
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Major target limb amputation within 36, 48, and 60 months as reported by site and adjudicated by CEC.
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Timepoint [20]
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36 months, 48 months, 60 months
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Secondary outcome [21]
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Proportion of Participants With a Thrombosis at the Target Lesion
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Assessment method [21]
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Thrombosis at target lesions within 36, 48, and 60 months as reported by the site and adjudicated by the CEC.
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Timepoint [21]
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36months, 48 months, 60 months
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Eligibility
Key inclusion criteria
- Subject is =18 years.
- Subject has target limb Rutherford classification 2, 3 or 4.
- Subject has provided written informed consent and is willing to comply with study
follow-up requirements.
- De novo lesion(s) or non-stented restenotic lesion(s) occurring >90 days after prior
plain old balloon (POBA) angioplasty or >180 days after prior DCB treatment.
- Target lesion location starts =10 mm below the common femoral bifurcation and
terminates distally at or above the end of the P1 segment of the popliteal artery.
- Target vessel diameter =4 mm and =7 mm.
- Target lesion must have angiographic evidence of =70% stenosis by operator visual
estimate.
- Chronic total occlusions may be included only after successful, uncomplicated wire
crossing of target lesion via an anterograde approach and without the use of
subintimal dissection techniques.
- Target lesion must be =180 mm in length (one long lesion or multiple serial lesions)
by operator visual estimate. Note: combination lesions must have a total lesion length
of =180 mm by visual estimate and be separated by =30 mm.
- Target lesion is located at least 30 mm from any stent, if target vessel was
previously stented.
- Successful, uncomplicated (without use of a crossing device) wire crossing of target
lesion. Successful crossing of the target lesion occurs when the tip of the guide wire
is distal to the target lesion without the occurrence of flow-limiting dissection or
perforation and is judged by visual inspection to be within the true lumen.
- After pre-dilatation, the target lesion is =70% residual stenosis, absence of a flow
limiting dissection and treatable with available device matrix.
- A patent inflow artery free from significant stenosis (=50% stenosis) as confirmed by
angiography.
- At least one patent native outflow artery to the ankle or foot, free from significant
stenosis (=50% stenosis) as confirmed by angiography.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subject has acute limb ischemia.
- Subject underwent percutaneous transluminal angioplasty (PTA) of the target limb using
plain old balloon angioplasty (POBA) or a stent within the previous 90 days.
- Subject underwent any lower extremity percutaneous treatment using a
paclitaxel-eluting stent or a DCB within the previous 90 days.
- Subject underwent PTA of the target lesion using a DCB within the previous 180 days.
- Subject has had prior vascular intervention in the contralateral limb within 14 days
before the planned study index procedure or subject has planned vascular intervention
in the contralateral limb within 30 days after the index procedure.
- Subject is pregnant, breast-feeding or intends to become pregnant during the time of
the study.
- Subject has life expectancy less than 2 years.
- Subject has a known allergy to contrast medium that cannot be adequately
pre-medicated.
- Subject is allergic to ALL antiplatelet treatments.
- Subject has impaired renal function (i.e. serum creatinine level =2.5 mg/dL).
- Subject is dialysis dependent.
- Subject is receiving immunosuppressant therapy.
- Subject has known or suspected active infection at the time of the index procedure.
- Subject has platelet count <100,000/mm3 or >700,000/mm3.
- Subject has history of gastrointestinal hemorrhage requiring a transfusion within 3
months prior to the study procedure.
- Subject is diagnosed with coagulopathy that precludes treatment with systemic
anticoagulation and/or dual antiplatelet therapy (DAPT).
- Subject has history of stroke within the past 90 days.
- Subject has a history of myocardial infarction within the past 30 days.
- Subject is unable to tolerate blood transfusions because of religious beliefs or other
reasons.
- Subject is incarcerated, mentally incompetent, or abusing drugs or alcohol.
- Subject is participating in another investigational drug or medical device study that
has not completed primary endpoint(s) evaluation or that clinically interferes with
the endpoints from this study, or subject is planning to participate in such studies
prior to the completion of this study.
- Subject has had any major (e.g. cardiac, peripheral, abdominal) surgical procedure or
intervention unrelated to this study within 30 days prior to the index procedure or
has planned major surgical procedure or intervention within 30 days of the index
procedure.
- Subject had previous bypass surgery of the target lesion.
- Subject had previous treatment of the target vessel with thrombolysis or surgery.
- Subject is unwilling or unable to comply with procedures specified in the protocol or
has difficulty or inability to return for follow-up visits as specified by the
protocol.
- Target lesion has severe calcification (as defined by the PARC classification of
calcification).
- Target lesion involves an aneurysm or is adjacent to an aneurysm (within 5 mm).
- Target lesion requires treatment with alternative therapy such as stenting, laser,
atherectomy, cryoplasty, brachytherapy, re-entry devices, or subintimal dissection
techniques.
- Significant target vessel tortuosity or other parameters prohibiting access to the
target lesion.
- Presence of thrombus in the target vessel.
- Iliac inflow disease requiring treatment, unless the iliac artery disease is
successfully treated first during the index procedure. Success is defined as =30%
residual diameter stenosis without death or major complications.
- Presence of an aortic, iliac or femoral artificial graft.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/10/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
446
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Prince of Wales Private Hostpital - Randwick
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Recruitment postcode(s) [1]
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- Randwick
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
California
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Connecticut
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Country [5]
0
0
United States of America
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State/province [5]
0
0
District of Columbia
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Florida
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Georgia
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Illinois
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Indiana
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Iowa
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Kansas
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Louisiana
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Massachusetts
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Michigan
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Minnesota
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Mississippi
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Country [17]
0
0
United States of America
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0
0
Missouri
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Nebraska
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Country [19]
0
0
United States of America
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State/province [19]
0
0
New Jersey
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Country [20]
0
0
United States of America
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State/province [20]
0
0
New York
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Country [21]
0
0
United States of America
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State/province [21]
0
0
North Carolina
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Country [22]
0
0
United States of America
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0
0
Ohio
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Country [23]
0
0
United States of America
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0
0
Oklahoma
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0
0
United States of America
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0
0
Oregon
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Country [25]
0
0
United States of America
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0
0
Pennsylvania
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Country [26]
0
0
United States of America
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0
0
Rhode Island
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Country [27]
0
0
United States of America
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0
0
Tennessee
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0
0
United States of America
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0
0
Texas
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0
0
Austria
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State/province [29]
0
0
Graz
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0
0
Belgium
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0
0
Dendermonde
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0
0
Belgium
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State/province [31]
0
0
Ghent
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Country [32]
0
0
Czechia
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State/province [32]
0
0
Brno
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Country [33]
0
0
Czechia
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State/province [33]
0
0
Ostrava
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Country [34]
0
0
Germany
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State/province [34]
0
0
Bad Krozingen
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Country [35]
0
0
Germany
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State/province [35]
0
0
Karlsbad
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Country [36]
0
0
Germany
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State/province [36]
0
0
Leipzig
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Country [37]
0
0
Germany
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State/province [37]
0
0
Sonneberg
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Country [38]
0
0
Italy
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State/province [38]
0
0
Florence
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Country [39]
0
0
Latvia
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State/province [39]
0
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Riga
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Country [40]
0
0
New Zealand
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State/province [40]
0
0
Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
SurModics, Inc.
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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
To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment
of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral
and/or popliteal arteries.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03241459
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Trial related presentations / publications
Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. doi: 10.1161/CIRCULATIONAHA.106.174526. No abstract available.
Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available.
Laird JR, Schneider PA, Tepe G, Brodmann M, Zeller T, Metzger C, Krishnan P, Scheinert D, Micari A, Cohen DJ, Wang H, Hasenbank MS, Jaff MR; IN.PACT SFA Trial Investigators. Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA. J Am Coll Cardiol. 2015 Dec 1;66(21):2329-2338. doi: 10.1016/j.jacc.2015.09.063. Epub 2015 Oct 14.
Rosenfield K, Jaff MR, White CJ, Rocha-Singh K, Mena-Hurtado C, Metzger DC, Brodmann M, Pilger E, Zeller T, Krishnan P, Gammon R, Muller-Hulsbeck S, Nehler MR, Benenati JF, Scheinert D; LEVANT 2 Investigators. Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease. N Engl J Med. 2015 Jul 9;373(2):145-53. doi: 10.1056/NEJMoa1406235. Epub 2015 Jun 24.
Patel MR, Conte MS, Cutlip DE, Dib N, Geraghty P, Gray W, Hiatt WR, Ho M, Ikeda K, Ikeno F, Jaff MR, Jones WS, Kawahara M, Lookstein RA, Mehran R, Misra S, Norgren L, Olin JW, Povsic TJ, Rosenfield K, Rundback J, Shamoun F, Tcheng J, Tsai TT, Suzuki Y, Vranckx P, Wiechmann BN, White CJ, Yokoi H, Krucoff MW. Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC). J Am Coll Cardiol. 2015 Mar 10;65(9):931-41. doi: 10.1016/j.jacc.2014.12.036. Erratum In: J Am Coll Cardiol. 2015 Jun 16;65(23):2578-9.
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William Gray, MD
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Lankenau Heart Group
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03241459
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