The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
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.
Who can participate
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
Prevail DCB
DEVICE
Agent DCB
DEVICE
Locations
51
United States (51)
Lehigh Valley Hospital - Cedar Crest
Allentown , Pennsylvania
AnMed Health Medical Center
Anderson , South Carolina
University of Michigan Health System - University Hospital
Ann Arbor , Michigan
Emory University Hospital Midtown
Atlanta , Georgia
Piedmont Atlanta Hospital
Atlanta , Georgia
The University of Alabama at Birmingham
Birmingham , Alabama
Kaleida Health
Buffalo , New York
Virtua Our Lady of Lourdes Hospital
Camden , New Jersey
Medical University of South Carolina (MUSC)
Charleston , South Carolina
Advocate Illinois Masonic Medical Center
Chicago , Illinois
The Lindner Research Center
Cincinnati , Ohio
BayCare Health System
Clearwater , Florida
University Hospitals Cleveland Medical Center
Cleveland , Ohio
OhioHealth Riverside Methodist Hospital
Columbus , Ohio
Baylor Heart & Vascular Hospital
Dallas , Texas
Saint Elizabeth Healthcare
Edgewood , Kentucky
M Health Fairview Clinic
Edina , Minnesota
Parkview Health
Fort Wayne , Indiana
North Florida Regional Medical Center
Gainesville , Florida
Corewell Health
Grand Rapids , Michigan
The Moses H Cone Memorial Hospital
Greensboro , North Carolina
UPMC Pinnacle Harrisburg Campus
Harrisburg , Pennsylvania
HCA Houston Medical Center
Houston , Texas
Huntsville Hospital
Huntsville , Alabama
University of Kansas Medical Center
Kansas City , Kansas
Saint Lukes Mid America Heart Institute
Kansas City , Missouri
Gundersen Lutheran
La Crosse , Wisconsin
John L McClellan Memorial Veterans Hospital
Little Rock , Arkansas
Medical Center of the Rockies
Loveland , Colorado
University of Miami Hospital
Miami , Florida
Providence Saint Patrick Hospital
Missoula , Montana
Midwest Cardiovascular Institute
Naperville , Illinois
TriStar Centennial Medical Center
Nashville , Tennessee
Vanderbilt University Medical Center
Nashville , Tennessee
Cumc/Nyph
New York , New York
Montefiore Medical Center
New York , New York
Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)
Overland Park , Kansas
The Valley Hospital
Paramus , New Jersey
Hospital of the University of Pennsylvania
Philadelphia , Pennsylvania
The Heart Hospital Baylor Plano
Plano , Texas
Oregon Health & Science University Hospital
Portland , Oregon
Rhode Island Hospital and Health Services - Lifespan
Providence , Rhode Island
Saint Francis Hospital (Roslyn NY)
Roslyn , New York
CentraCare Heart & Vascular Center MN - Saint Cloud Hospital
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