Back to Trials
NCT06535854NARecruiting

Prevail Global Study

Medtronic Vascular

Start Date

2/24/2025

Completion Date

2/1/2031

Summary

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

Detailed Description

The Prevail Global study is a prospective, premarket, interventional, multi-center, global, dual cohort clinical study enrolling subjects undergoing percutaneous coronary intervention for in-stent restenosis (ISR Cohort) in a randomized controlled study of the Prevail Drug-Coated Balloon, and subjects undergoing percutaneous coronary intervention of the Prevail Drug-Coated Balloon for de novo lesions in small vessel disease (DNSV Cohort) in a single arm prospectively enrolled study. In the ISR Cohort this will be accomplished by randomizing subjects to either a Prevail DCB arm or an Agent DCB arm to compare results of the treatment of ISR with coronary lesions previously treated with DES or BMS in native coronary arteries. In the DNSV Cohort this will be accomplished through collection of data to compare results of the Prevail DCB to a DES historical control in subjects undergoing PCI for de novo lesions in small vessel disease. Subjects will be enrolled at approximately 65 study sites; the same study sites will be used for enrollment of both cohorts. The enrollment period is anticipated to be approximately 12 months. Subjects will remain in the study with follow-up clinical assessments through 5 years, study exit, or death, whichever comes first.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * ≥ 18 years * Negative pregnancy test * Stable or unstable angina, positive functional test, or stable NSTEMI * Life expectancy \>1 year * Willing and able to cooperate with study procedures and required follow up evaluations Exclusion Criteria: * Known hypersensitivity or contraindication to antiplatelet medications or a sensitivity to contrast media which cannot be adequately pre-medicated * History of an allergic reaction or significant sensitivity to paclitaxel or any other analogue or derivative * Platelet count \< 100,000 cells/mm³ or \> 700,000 cells/mm³, or a white blood cell (WBC) count \< 3,000 cells/mm³ * Renal insufficiency (or failure) * Acute MI * Previous PCI of the target vessel within 6 months prior to the procedure * Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of the target vessel within 12 months post-procedure * History of a stroke or transient ischemic attack (TIA) * Active peptic ulcer or upper gastrointestinal (GI) bleeding * History of bleeding diathesis or coagulopathy or will refuse blood transfusions * Documented left ventricular ejection fraction (LVEF) \<30% * Planned surgery that would cause interruption in recommended DAPT duration per current guidelines * Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires additional coronary angiography, IVUS or other coronary artery imaging procedures

Interventions

DEVICE

Prevail DCB

DEVICE

Agent DCB

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Coronary Artery Disease

Locations

The University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

Huntsville Hospital

Huntsville, Alabama 35801

United States

Carondelet Saint Marys

Tucson, Arizona 85745

United States

John L McClellan Memorial Veterans Hospital

Little Rock, Arkansas 72205

United States

Stanford Hospital & Clinics

Stanford, California 94305

United States

Medical Center of the Rockies

Loveland, Colorado 80538

United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia 20010

United States

BayCare Health System

Clearwater, Florida 33756

United States

North Florida Regional Medical Center

Gainesville, Florida 32605

United States

University of Miami Hospital

Miami, Florida 33136

United States

Emory University Hospital Midtown

Atlanta, Georgia 30308

United States

Piedmont Atlanta Hospital

Atlanta, Georgia 30309

United States

Advocate Illinois Masonic Medical Center

Chicago, Illinois 60657

United States

Midwest Cardiovascular Institute

Naperville, Illinois 60540

United States

Parkview Health

Fort Wayne, Indiana 46845

United States

University of Kansas Medical Center

Kansas City, Kansas 66160

United States

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

Overland Park, Kansas 66211

United States

Ascension Via Christi Saint Francis

Wichita, Kansas 67214

United States

Saint Elizabeth Healthcare

Edgewood, Kentucky 41017

United States

University of Michigan Health System - University Hospital

Ann Arbor, Michigan 48109

United States

Corewell Health

Grand Rapids, Michigan 49503

United States

Saint Joseph Mercy Ann Arbor

Ypsilanti, Michigan 48197

United States

M Health Fairview Clinic

Edina, Minnesota 55435

United States

CentraCare Heart & Vascular Center MN - Saint Cloud Hospital

Saint Cloud, Minnesota 56303

United States

Saint Lukes Mid America Heart Institute

Kansas City, Missouri 64111

United States

Providence Saint Patrick Hospital

Missoula, Montana 59802

United States

Virtua Our Lady of Lourdes Hospital

Camden, New Jersey 08103

United States

The Valley Hospital

Paramus, New Jersey 07652

United States

Kaleida Health

Buffalo, New York 14214

United States

Cumc/Nyph

New York, New York 10032

United States

Montefiore Medical Center

New York, New York 10467

United States

Saint Francis Hospital (Roslyn NY)

Roslyn, New York 11576

United States

The Moses H Cone Memorial Hospital

Greensboro, North Carolina 27401

United States

Novant Health New Hanover Regional Medical Center

Wilmington, North Carolina 28401

United States

The Lindner Research Center

Cincinnati, Ohio 45219

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

OhioHealth Riverside Methodist Hospital

Columbus, Ohio 43214

United States

Oregon Health & Science University Hospital

Portland, Oregon 97239

United States

Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania 18103

United States

UPMC Pinnacle Harrisburg Campus

Harrisburg, Pennsylvania 17101

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Rhode Island Hospital and Health Services - Lifespan

Providence, Rhode Island 02903

United States

AnMed Health Medical Center

Anderson, South Carolina 29621

United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina 29425

United States

TriStar Centennial Medical Center

Nashville, Tennessee 37203

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Baylor Heart & Vascular Hospital

Dallas, Texas 75226

United States

HCA Houston Medical Center

Houston, Texas 77004

United States

The Heart Hospital Baylor Plano

Plano, Texas 75093

United States

University of Washington (UW) Medical Center

Seattle, Washington 98195

United States

Gundersen Lutheran

La Crosse, Wisconsin 54601

United States