Tests a drug-coated balloon for narrowed heart arteries
Tests the Prevail drug-coated balloon in adults with coronary artery disease.
Plain-language title generated from the registry record
Registry title: Prevail Global Study
Key facts
- Where
- Allentown, Anderson, Ann Arbor, Atlanta, Birmingham, Buffalo, Camden, Charleston, Chicago, Cincinnati, Clearwater, Cleveland, Columbus, Dallas, Edgewood, Edina, Fort Wayne, Gainesville, Grand Rapids, Greensboro, Harrisburg, Houston, Huntsville, Kansas City, La Crosse, Little Rock, Louisville, Loveland, Manhasset, Miami, Minneapolis, Missoula, Naperville, Nashville, New York, Overland Park, Paramus, Philadelphia, Plano, Portland, Providence, Roslyn, Saint Cloud, Seattle, Stanford, Tucson, Washington D.C., Wichita, Wilmington, and Ypsilanti, United StatesSee the 55 sites
Where in United States
- Lehigh Valley Hospital-Cedar CrestAllentown, United StatesTaking people
- AnMed Health Medical CenterAnderson, United StatesTaking people
- University of Michigan Health System - University HospitalAnn Arbor, United StatesTaking people
- Emory University Hospital MidtownAtlanta, United StatesTaking people
- Piedmont Atlanta HospitalAtlanta, United StatesTaking people
- Cardiology, P.C.Birmingham, United StatesTaking people
- The University of Alabama at BirminghamBirmingham, United StatesTaking people
- Kaleida HealthBuffalo, United StatesTaking people
- Virtua Our Lady of Lourdes HospitalCamden, United StatesTaking people
- Medical University of South Carolina (MUSC)Charleston, United StatesTaking people
- Advocate Illinois Masonic Medical CenterChicago, United StatesTaking people
- The Lindner Research CenterCincinnati, United StatesTaking people
- BayCare Health SystemClearwater, United StatesTaking people
- University Hospitals Cleveland Medical Center*Cleveland, United StatesTaking people
- OhioHealth Riverside Methodist HospitalColumbus, United StatesTaking people
- Baylor Heart & Vascular HospitalDallas, United StatesTaking people
- Saint Elizabeth HealthcareEdgewood, United StatesTaking people
- M Health Fairview ClinicEdina, United StatesNo longer taking part
- Parkview HealthFort Wayne, United StatesTaking people
- North Florida Regional Medical CenterGainesville, United StatesTaking people
- Corewell HealthGrand Rapids, United StatesTaking people
- The Moses H Cone Memorial HospitalGreensboro, United StatesTaking people
- UPMC Pinnacle Harrisburg CampusHarrisburg, United StatesTaking people
- HCA Houston Medical CenterHouston, United StatesTaking people
- Huntsville HospitalHuntsville, United StatesTaking people
- Saint Lukes Mid America Heart InstituteKansas City, United StatesTaking people
- University of Kansas Medical CenterKansas City, United StatesTaking people
- Gundersen LutheranLa Crosse, United StatesTaking people
- John L McClellan Memorial Veterans HospitalLittle Rock, United StatesTaking people
- Norton Heart and Vascular InstituteLouisville, United StatesTaking people
- Medical Center of the RockiesLoveland, United StatesTaking people
- Northwell Health North Shore University HospitalManhasset, United StatesTaking people
- University of Miami HospitalMiami, United StatesTaking people
- Abbott-Northwestern HospitalMinneapolis, United StatesTaking people
- Providence Saint Patrick HospitalMissoula, United StatesTaking people
- Midwest Cardiovascular InstituteNaperville, United StatesTaking people
- TriStar Centennial Medical centerNashville, United StatesTaking people
- Vanderbilt University Medical CenterNashville, United StatesTaking people
- Cumc/NyphNew York, United StatesTaking people
- Montefiore Medical CenterNew York, United StatesTaking people
- Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)Overland Park, United StatesTaking people
- The Valley HospitalParamus, United StatesTaking people
- Hospital of the University of PennsylvaniaPhiladelphia, United StatesTaking people
- The Heart Hospital Baylor PlanoPlano, United StatesTaking people
- Oregon Health & Science University HospitalPortland, United StatesTaking people
- Rhode Island Hospital and Health Services - LifespanProvidence, United StatesTaking people
- Saint Francis Hospital (Roslyn NY)Roslyn, United StatesTaking people
- CentraCare Heart & Vascular Center MN - Saint Cloud HospitalSaint Cloud, United StatesTaking people
- University of Washington (UW) Medical CenterSeattle, United StatesTaking people
- Stanford Hospital & ClinicsStanford, United StatesTaking people
- Carondelet Saint MarysTucson, United StatesTaking people
- MedStar Washington Hospital CenterWashington D.C., United StatesTaking people
- Ascension Via Christi Saint FrancisWichita, United StatesTaking people
- Novant Health New Hanover Regional Medical CenterWilmington, United StatesTaking people
- Saint Joseph Mercy Ann ArborYpsilanti, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medtronic Vascular
- Trial code
- NCT06535854
- Record updated
- 21 October 2026
- Original description
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.Read full original descriptionShow less
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).
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
Inclusion: ≥ 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: Previous PCI of the target vessel within 6 months prior to the procedure; 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; 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; Renal insufficiency (or failure); 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; Platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (WBC) count < 3,000 cells/mm³; Documented left ventricular ejection fraction (LVEF) <30%; Acute MI; Planned PCI of any vessel within 72 hours post-index procedure and/or planned PCI of the target vessel within 12 months post-procedure.