Prevail Global Study
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
Interventions
Prevail DCB
Agent DCB
Conditions
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