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

SurModics, Inc.63 sites in 1 country446 target enrollmentOctober 23, 2017

ConditionsPeripheral Arterial Disease Peripheral Vascular Disease Artery Disease, Peripheral Femoropopliteal Artery Occlusion

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: SurModics, Inc.
Enrollment: 446
Locations: 63
Primary Endpoint: Primary Lesion Patency Though 12 Months
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Detailed Description

TRANSCEND is a prospective, multi-center, single-blind, randomized, controlled, noninferiority clinical trial. The trial will randomize approximately 446 subjects with symptomatic PAD due to stenoses of the femoral and/or popliteal arteries. Subjects meeting eligibility criteria will be randomized 1:1 to treatment with either the SurVeil DCB or the IN.PACT Admiral DCB, and followed for 60 months.

Registry

clinicaltrials.gov

Start Date

October 23, 2017

End Date

September 17, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

SurModics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is ≥18 years.
•Subject has target limb Rutherford classification 2, 3 or
•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.

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).

Outcomes

Primary Outcomes

Primary Lesion Patency Though 12 Months

Time Frame: 12 months

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.

Safety Composite of Freedom From Death, Amputation, and Target Vessel Revascularization (TVR)

Time Frame: 12 months

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.

Secondary Outcomes

Proportion of Participants With Device Success(Day 0)
Proportion of Participants With Technical Success(Day 0)
Proportion of Participants With Procedure Success(72 hours)
Freedom From All-cause Death, Major Target Limb Amputation and TVR Through 30 Days(30 days)
Proportion of Participants With Primary Lesion Patency(24 months)
Proportion of Participants With Target Vessel Patency(12 months, 24 months)
Proportion of Participants With Sustained Clinical Improvement(6 months, 12 months, 24 months)
Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR)(36 months, 48 months, 60 months)
Proportion of Participants With a Historical Major Adverse Events (MAEs)(36 months, 48 months, 60 months)
Proportion of Participants With a Major Target Limb Amputation(36 months, 48 months, 60 months)
Proportion of Participants With a Thrombosis at the Target Lesion.(6 months, 12 months, 24 months)
Change in Target Limb Rutherford Class(Baseline, 1 month, 6 months, 12 months, and 24 months)
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class(Screening, 1 month, 6 months, 12 months, and 24 months)
Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI)(Screening, 6 months, 12 months, and 24 months)
Change in Walking Impairment Questionnaire (WIQ)(Screening, 1 month, 12 months, and 24 months)
Change in 6-Minute Walk Test (6MWT)(Screening, 12 months, and 24 months)
Change in Peripheral Artery Questionnaire (PAQ)(Screening, 1 month, 12 months, and 24 months)
Proportion of Participants With a Thrombosis at the Target Lesion(36 months, 48 months, 60 months)