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RECRUITING
NCT06535854
NA

Prevail Global Study

Sponsor: Medtronic Vascular

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.

Official title: A Randomized Controlled Study of the Prevail Drug-Coated Balloon in Subjects With In-stent Restenosis and a Single Arm Prospectively Enrolled Study of the Prevail Drug-Coated Balloon for de Novo Lesions in Small Vessel Disease (Prevail Global).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1205

Start Date

2025-02-24

Completion Date

2031-02

Last Updated

2026-10-21

Healthy Volunteers

No

Interventions

DEVICE

Prevail DCB

The Prevail Paclitaxel-coated PTCA Balloon Catheter is intended for percutaneous transluminal coronary angioplasty (PTCA) in the coronary arteries with a vessel diameter from 2.00 mm to 4.00 mm to treat in-stent restenosis (ISR) and to treat de novo lesions in small vessel disease.

DEVICE

Agent DCB

The Agent Paclitaxel-coated PTCA Balloon Catheter is intended for percutaneous transluminal coronary angioplasty (PTCA) in the coronary arteries with a vessel diameter from 2.00 mm to 4.00 mm to treat in-stent restenosis (ISR).

Locations (79)

Cardiology P.C.

Birmingham, Alabama, United States

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Huntsville Hospital

Huntsville, Alabama, United States

Carondelet Saint Marys

Tucson, Arizona, United States

John L McClellan Memorial Veterans Hospital

Little Rock, Arkansas, United States

Stanford Hospital & Clinics

Stanford, California, United States

Medical Center of the Rockies

Loveland, Colorado, United States

Medstar Washington Hospital Center

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

BayCare Health System

Clearwater, Florida, United States

North Florida Regional Medical Center

Gainesville, Florida, United States

University of Miami Hospital

Miami, Florida, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Piedmont Atlanta Hospital

Atlanta, Georgia, United States

Advocate Illinois Masonic Medical Center

Chicago, Illinois, United States

Midwest Cardiovascular Institute

Naperville, Illinois, United States

Parkview Health

Fort Wayne, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)

Overland Park, Kansas, United States

Ascension Via Christi Saint Francis

Wichita, Kansas, United States

Saint Elizabeth Healthcare

Edgewood, Kentucky, United States

Norton Heart and Vascular Institute

Louisville, Kentucky, United States

University of Michigan Health System - University Hospital

Ann Arbor, Michigan, United States

Corewell Health

Grand Rapids, Michigan, United States

Saint Joseph Mercy Ann Arbor

Ypsilanti, Michigan, United States

M Health Fairview Clinic

Edina, Minnesota, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

CentraCare Heart & Vascular Center MN - Saint Cloud Hospital

Saint Cloud, Minnesota, United States

Saint Lukes Mid America Heart Institute

Kansas City, Missouri, United States

Providence Saint Patrick Hospital

Missoula, Montana, United States

Virtua Our Lady of Lourdes Hospital

Camden, New Jersey, United States

The Valley Hospital

Paramus, New Jersey, United States

Kaleida Health

Buffalo, New York, United States

Northwell Health North Shore University Hospital

Manhasset, New York, United States

Cumc/Nyph

New York, New York, United States

Montefiore Medical Center

New York, New York, United States

Saint Francis Hospital (Roslyn NY)

Roslyn, New York, United States

The Moses H Cone Memorial Hospital

Greensboro, North Carolina, United States

Novant Health New Hanover Regional Medical Center

Wilmington, North Carolina, United States

The Lindner Research Center

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, United States

Oregon Health & Science University Hospital

Portland, Oregon, United States

Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania, United States

UPMC Pinnacle Harrisburg Campus

Harrisburg, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Rhode Island Hospital and Health Services - Lifespan

Providence, Rhode Island, United States

AnMed Health Medical Center

Anderson, South Carolina, United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

TriStar Centennial Medical Center

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor Heart & Vascular Hospital

Dallas, Texas, United States

HCA Houston Medical Center

Houston, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

University of Washington (UW) Medical Center

Seattle, Washington, United States

Gundersen Lutheran

La Crosse, Wisconsin, United States

Hôpital du Sacre Coeur de Montreal

Montreal, Canada

Montreal Heart Institute

Montreal, Canada

University of Ottawa Heart Institute

Ottawa, Canada

Toronto General Hospital

Toronto, Canada

Vancouver General Hospital

Vancouver, Canada

Herzzentrum Dresden GmbH Universitätsklinik

Dresden, Germany

Universitat des Saarlandes

Homburg, Germany

MediClin Herzzentrum Lahr / Baden

Lahr, Germany

Queen Mary Hospital

Hong Kong, Hong Kong

Mater Private Network

Dublin, Ireland

Galway University Hospitals - University Hospital Galway (UHG)

Galway, Ireland

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Saiseikai Yokohamashi Tobu Hospital

Yokohama, Kanagawa, Japan

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Teikyo University Hospital

Itabashi-ku, Tokyo, Japan

Sengkang General Hospital

Singapore, Singapore

Tan Tock Seng Hospital

Singapore, Singapore

Keimyung University Dongsan Hospital

Daegu, South Korea

Asan Medical Center

Seoul, South Korea

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Seoul Saint Marys Hospital

Seoul, South Korea

The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

Newcastle upon Tyne, United Kingdom