Prevail Global Study
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).
1 other identifier
interventional
1,205
1 country
51
Brief Summary
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Feb 2025
Longer than P75 for not_applicable coronary-artery-disease
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2024
CompletedFirst Posted
Study publicly available on registry
August 2, 2024
CompletedStudy Start
First participant enrolled
February 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2031
April 24, 2026
April 1, 2026
1.9 years
July 30, 2024
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
ISR Cohort Primary Analysis
The TLF rate of the Prevail DCB arm at 12 months post procedure compared to the Agent DCB arm for non-inferiority
1 year post-procedure
DNSV Cohort Primary Analysis
The TLF rate of the Prevail DCB arm at 12 months post procedure compared to a DES historical control
1 year post-procedure
Secondary Outcomes (10)
Acute success
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
All deaths
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Cardiac death
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
All myocardial infarction (MI), including target vessel myocardial infarction (TVMI)
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Clinically-driven target lesion revascularization (cd-TLR) defined as repeat PCI or CABG to the target lesion
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
- +5 more secondary outcomes
Study Arms (2)
ISR Cohort Prevail DCB
EXPERIMENTALTo evaluate the clinical safety and efficacy of the Prevail DCB in the treatment of ISR with coronary lesions previously treated with drug-eluting or bare metal stents in native coronary arteries.
DNSV Cohort (RVD 2.0 - 2.75mm)
EXPERIMENTALTo evaluate the clinical safety and efficacy of the Prevail DCB as compared to a DES historical control in subjects undergoing PCI for de novo lesions in small vessel disease.
Interventions
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.
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).
Eligibility Criteria
You may qualify if:
- ≥ 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
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
Related Publications (1)
Kandzari DE, Latib A, Mylotte D, Ali ZA, Zaman A, Brar S, Parke M, Scheller B. Rationale and design of the prevail global trial program evaluating the prevail drug-coated balloon in patients with in-stent restenosis and de novo small vessel disease. Am Heart J. 2025 May;283:26-36. doi: 10.1016/j.ahj.2025.01.010. Epub 2025 Jan 23.
PMID: 39863032DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Kandzari
Piedmont Heart Institute
- PRINCIPAL INVESTIGATOR
Bruno Scheller
University of Saarland
- PRINCIPAL INVESTIGATOR
Azeem Latib
Montefiore Health System
- PRINCIPAL INVESTIGATOR
Darren Mylotte
Galway University Hospitals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Masking only applies to the subjects in the ISR Cohort, subjects will be randomized at a 1:1 ratio to treatment with the Prevail DCB or the Agent DCB. Subjects in DNSV Cohort will be prospectively enrolled in the study and treated with Prevail DCB.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2024
First Posted
August 2, 2024
Study Start
February 24, 2025
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2031
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share