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Completed Not applicable Interventional Results available

Safety and Efficacy of the SurVeil™ Drug-Coated Balloon

ClinicalTrials.gov ID: NCT03241459

Public ClinicalTrials.gov record NCT03241459. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 9:02 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03241459
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
SurModics, Inc.
Industry
Enrollment
446 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 23, 2017 (Actual)
Primary completion
Sep 15, 2020 (Actual)
Completion
Sep 17, 2024 (Actual)
Last update posted
Mar 25, 2025

2017 – 2024

United States locations

U.S. sites
50
U.S. states
28
U.S. cities
48
Facility City State ZIP Site status
Cardiovascular Associates of the Southeast Birmingham Alabama 35243 —
Cardiology Associates Foley Alabama 36535 —
Dignity Health Gilbert Arizona 85297 —
Yuma Regional Medical Center Yuma Arizona 85364 —
Mission Cardiovascular Research Institute Fremont California 94538 —
Yale New Haven Hospital New Haven Connecticut 06510 —
MedStar Washington Hospital Center Washington D.C. District of Columbia 20010 —
Clearwater Cardiovascular Consultants Clearwater Florida 33756 —
Advent Health Ocala/MediQuest Research Group LLC (formerly FL Hospital /Munroe) Ocala Florida 34478 —
Piedmont Heart Insitute Atlanta Georgia 30309 —
Emory University Hospital (Clifton) Atlanta Georgia 30322 —
Northeast Georgia Medical Center Gainesville Georgia 30501 —
Alexian Brothers Medical Center Elk Grove Village Illinois 60007 —
Advocate Health Naperville Illinois 60540 —
Prairie Education (PERC) Springfield Illinois 62701 —
St Vincent Heart (Research Department) Indianapolis Indiana 46290 —
Iowa Heart Center West Des Moines Iowa 50266 —
University of Kansas Medical Center Kansas City Kansas 66160 —
Endovascular Technologies, LLC Bossier City Louisiana 71111 —
Cardiovascular Associates Research Covington Louisiana 70433 —
St. Elizabeth's Medical Center Boston Massachusetts 02135 —
Beth Israel Deaconess Boston Massachusetts 02215 —
Northern Michigan Hospital Petoskey Michigan 49770 —
North Memorial Hospital Robbinsdale Minnesota 55422 —
Hattiesburg Clinic Hattiesburg Mississippi 39401 —
Mercy Hospital Springfield Missouri 65804 —
University of Nebraska Omaha Nebraska 68198 —
Virtua Medical Group, P.A. Cherry Hill New Jersey 08034 —
St. Michael's Hospital Newark New Jersey 07102 —
Holy Name Medical Center Teaneck New Jersey 07666 —
Columbia University Medical Center/NYPH New York New York 10032 —
Mission Hospital Asheville North Carolina 28801 —
Moses Cone-LeBauer Greensboro North Carolina 27401 —
North Carolina Heart and Vascular Raleigh North Carolina 27607 —
The Lindner Clinical Trial Center Cincinnati Ohio 45219 —
Cleveland Clinic Cleveland Ohio 44195 —
Ohio Health Research Institute Columbus Ohio 43214 —
North Ohio Heart Center Elyria Ohio 44035 —
University of Toledo Medical Center Toledo Ohio 43614 —
Oklahoma Cardiovascular Research Group Oklahoma City Oklahoma 73120 —
Providence Heart and Vascular Portland Oregon 97225 —
Capital Area Research Camp Hill Pennsylvania 17011 —
Bryn Mawr Hospital - Main Line Health System (Einstein) Philadelphia Pennsylvania 19141 —
Pinnacle Health Cardiovascular Institute Wormleysburg Pennsylvania 17043 —
The Miriam Hospital Providence Rhode Island 02906 —
Ballad Health System Kingsport Tennessee 37660 —
Turkey Creek Medical Center Knoxville Tennessee 37934 —
St. David's Heart & Vascular PLLC dba Austin Heart Austin Texas 78756 —
Houston Cardiovascular Association Houston Texas 77030 —
North Dallas Research Associates McKinney Texas 75069 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03241459, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 25, 2025 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03241459 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →