New balloon could save legs from amputation in artery disease trial

NCT ID NCT06182397

Recruiting now Disease control Sponsor: Concept Medical Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a special balloon coated with sirolimus, a drug that helps keep arteries open, versus a standard balloon for people with severe leg artery disease below the knee. About 368 adults with advanced symptoms like pain at rest or non-healing wounds will be randomly assigned to one of the two treatments. The goal is to see if the drug-coated balloon better prevents re-blockage, avoids major amputation, and improves blood flow over 12 months.

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ARTERIAL DISEASE OF LEGS BELOW-THE-KNEE OBSTRUCTION PAD - PERIPHERAL ARTERIAL DISEASE

Contacts and locations

Locations

Ascension Seton Medical Center Austin
RECRUITING

Austin, Texas, 78705, United States
Atria Vascular and Vein
NOT_YET_RECRUITING

Farmington Hills, Michigan, 48334, United States
Baptist Hospital of Miami
RECRUITING

Miami, Florida, 33176, United States
Baylor Research Institute
RECRUITING

Dallas, Texas, 75226, United States
Cedars-Sinai Medical Center
RECRUITING

Los Angeles, California, 90048, United States
Clearwater Cardiovascular Consultants
RECRUITING

Clearwater, Florida, 33756, United States
Columbia University Irving Medical center/NYPH
RECRUITING

New York, New York, 10032, United States
Deborah Heart and Lung Center
RECRUITING

Browns Mills, New Jersey, 08015, United States
HOPE Vascular and Podiatry
RECRUITING

Houston, Texas, 77054, United States
Honor Health Research & Innovation Institute
RECRUITING

Scottsdale, Arizona, 85258, United States
Lankenau Institute for Medical Research Bryn Mawr Hospital
RECRUITING

Bryn Mawr, Pennsylvania, 19010, United States
Medical University of South Carolina(MUSC) Health Ashley River Tower
RECRUITING

Charleston, South Carolina, 29425, United States
NYU Langone Medical Center
RECRUITING

New York, New York, 10016, United States
New York Presbyterian - Weill Cornell Medical Center Vascular & Endovascular Surgery
RECRUITING

New York, New York, 10065, United States
Northwell Health Long Island Jewish Medical Center
RECRUITING

Lake Success, New York, 11042, United States
San Antonio Vascular and Endovascular Clinic
NOT_YET_RECRUITING

San Antonio, Texas, 78221, United States
St. Francis Hospital and Heart Center
NOT_YET_RECRUITING

Roslyn, New York, 11576, United States
The Christ Hospital Network Outpatient Center
RECRUITING

Cincinnati, Ohio, 45219, United States
The Heart Hospital Baylor Plano
RECRUITING

Plano, Texas, 75093, United States
The Mount Sinai Hospital
RECRUITING

New York, New York, 10029, United States
Unity Point Health Des Moines
RECRUITING

Des Moines, Iowa, 50309, United States
University Hospitals Cleveland Medical Center
RECRUITING

Cleveland, Ohio, 44106, United States
University of California Los Angeles
NOT_YET_RECRUITING

Los Angeles, California, 90095, United States
University of Pennsylvania - Penn Heart and Vascular Center
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
University of South Florida
RECRUITING

Tampa, Florida, 33606, United States
University of Washington Seattle
RECRUITING

Seattle, Washington, 98104, United States
Vascular Institute of the Midwest
RECRUITING

Davenport, Iowa, 52807, United States
Virtua Healthcare - Virtua Our Lady of Lourdes
RECRUITING

Marlton, New Jersey, 08053, United States
Westchester Medical Center
RECRUITING

Valhalla, New York, 10595, United States

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