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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 Jun 27, 2026, 9:07 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

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

Interventions

  • Surmodics SurVeil DCB Device
  • Medtronic IN.PACT Admiral DCB Device

Device

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 22, 2017
Primary completion
Sep 14, 2020
Completion
Sep 16, 2024
Last update posted
Mar 24, 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 24, 2025 · Synced Jun 27, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03241459 live on ClinicalTrials.gov.

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