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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

2025-10-24

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 (45)

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

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

Corewell Health

Grand Rapids, Michigan, United States

Saint Joseph Mercy Ann Arbor

Ypsilanti, Michigan, United States

M Health Fairview Clinic

Edina, 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

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

Rhode Island Hospital and Health Services - Lifespan

Providence, Rhode Island, United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

TriStar Centennial 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

Gundersen Lutheran

La Crosse, Wisconsin, United States