Loading clinical trials...

Safety and Efficacy of the SurVeil™ Drug-Coated Balloon | Clinical Trials | Clareo Health

COMPLETEDNA

Safety and Efficacy of the SurVeil™ Drug-Coated Balloon

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

NCT03241459•SurModics, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

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).
+22 more criteria

Locations (63)

Cardiovascular Associates of the Southeast

Birmingham, Alabama, United States

Cardiology Associates

Foley, Alabama, United States

Dignity Health

Gilbert, Arizona, United States

Yuma Regional Medical Center

Yuma, Arizona, United States

Mission Cardiovascular Research Institute

Fremont, California, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Clearwater Cardiovascular Consultants

Clearwater, Florida, United States

Advent Health Ocala/MediQuest Research Group LLC (formerly FL Hospital /Munroe)

Ocala, Florida, United States

Piedmont Heart Insitute

Atlanta, Georgia, United States

Key Dates

Start Date

October 23, 2017

Primary Completion Date

September 15, 2020

Completion Date

September 17, 2024

Last Updated

March 25, 2025

Enrollment

446

ACTUAL participants

Conditions

Peripheral Arterial DiseasePeripheral Vascular DiseaseArtery Disease, PeripheralFemoropopliteal Artery Occlusion

Interventions

Surmodics SurVeil DCB

DEVICE

Medtronic IN.PACT Admiral DCB

DEVICE

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

NCT07472049

Peripheral Arterial DiseaseChronic Limb Threatening Ischemia

View study

RECRUITING

Advanta VXT and Flixene PMCF Registry

NCT07161583

Peripheral Arterial Disease

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Efficacy of the SurVeil™ Drug-Coated Balloon

Inclusion Criteria

Exclusion Criteria

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

Advanta VXT and Flixene PMCF Registry

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

VITUS Post-Market Registry

A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)

The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)