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Prevail Global Study
Recruiting
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).
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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 72 hours 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
About the study
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
What is being tested
- Prevail DCB (device)
- Agent DCB (device)
Sponsor: Medtronic Vascular · Participants: 1,205 · Started: Feb 24, 2025
Contact the study team
Official record on ClinicalTrials.gov — NCT06535854
Locations in the U.S.
| Alabama | Cardiology P.C., Birmingham The University of Alabama at Birmingham, Birmingham Huntsville Hospital, Huntsville |
| Arizona | Carondelet Saint Marys, Tucson |
| Arkansas | John L McClellan Memorial Veterans Hospital, Little Rock |
| California | Stanford Hospital & Clinics, Stanford |
| Colorado | Medical Center of the Rockies, Loveland |
| District of Columbia | Medstar Washington Hospital Center, Washington D.C. |
| Florida | BayCare Health System, Clearwater North Florida Regional Medical Center, Gainesville University of Miami Hospital, Miami |
| Georgia | Emory University Hospital Midtown, Atlanta Piedmont Atlanta Hospital, Atlanta |
| Illinois | Advocate Illinois Masonic Medical Center, Chicago Midwest Cardiovascular Institute, Naperville |
| Indiana | Parkview Health, Fort Wayne |
| Kansas | University of Kansas Medical Center, Kansas City Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist), Overland Park Ascension Via Christi Saint Francis, Wichita |
| Kentucky | Saint Elizabeth Healthcare, Edgewood Norton Heart and Vascular Institute, Louisville |
| Michigan | University of Michigan Health System - University Hospital, Ann Arbor Corewell Health, Grand Rapids Saint Joseph Mercy Ann Arbor, Ypsilanti |
| Minnesota | Abbott Northwestern Hospital, Minneapolis CentraCare Heart & Vascular Center MN - Saint Cloud Hospital, Saint Cloud |
| Missouri | Saint Lukes Mid America Heart Institute, Kansas City |
| Montana | Providence Saint Patrick Hospital, Missoula |
| New Jersey | Virtua Our Lady of Lourdes Hospital, Camden The Valley Hospital, Paramus |
| New York | Kaleida Health, Buffalo Northwell Health North Shore University Hospital, Manhasset Cumc/Nyph, New York Montefiore Medical Center, New York Saint Francis Hospital (Roslyn NY), Roslyn |
| North Carolina | The Moses H Cone Memorial Hospital, Greensboro Novant Health New Hanover Regional Medical Center, Wilmington |
| Ohio | The Lindner Research Center, Cincinnati University Hospitals Cleveland Medical Center, Cleveland OhioHealth Riverside Methodist Hospital, Columbus |
| Oregon | Oregon Health & Science University Hospital, Portland |
| Pennsylvania | Lehigh Valley Hospital - Cedar Crest, Allentown UPMC Pinnacle Harrisburg Campus, Harrisburg Hospital of the University of Pennsylvania, Philadelphia |
| Rhode Island | Rhode Island Hospital and Health Services - Lifespan, Providence |
| South Carolina | AnMed Health Medical Center, Anderson Medical University of South Carolina (MUSC), Charleston |
| Tennessee | TriStar Centennial Medical Center, Nashville Vanderbilt University Medical Center, Nashville |
| Texas | Baylor Heart & Vascular Hospital, Dallas HCA Houston Medical Center, Houston The Heart Hospital Baylor Plano, Plano |
| Washington | University of Washington (UW) Medical Center, Seattle |
| Wisconsin | Gundersen Lutheran, La Crosse |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.