Prevail Global Study

Recruiting now · Not applicable

Conditions studied: Coronary Artery Disease

In brief

The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.

Key facts

Study ID

NCT06535854

Run by

Medtronic Vascular

People needed

1205

Starts

2025-02-24

Expected to finish

2031-02-01

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Huntsville Hospital — Huntsville, Alabama, United States (enrolling)
• Carondelet Saint Marys — Tucson, Arizona, United States (enrolling)
• John L McClellan Memorial Veterans Hospital — Little Rock, Arkansas, United States (enrolling)
• Stanford Hospital & Clinics — Stanford, California, United States (enrolling)
• Medical Center of the Rockies — Loveland, Colorado, United States (enrolling)
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
• BayCare Health System — Clearwater, Florida, United States (enrolling)
• North Florida Regional Medical Center — Gainesville, Florida, United States (enrolling)
• University of Miami Hospital — Miami, Florida, United States (enrolling)
• Emory University Hospital Midtown — Atlanta, Georgia, United States (enrolling)
• Piedmont Atlanta Hospital — Atlanta, Georgia, United States (enrolling)
• Advocate Illinois Masonic Medical Center — Chicago, Illinois, United States (enrolling)
• Midwest Cardiovascular Institute — Naperville, Illinois, United States (enrolling)
• Parkview Health — Fort Wayne, Indiana, United States (enrolling)
• University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
• Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist) — Overland Park, Kansas, United States (enrolling)
• Ascension Via Christi Saint Francis — Wichita, Kansas, United States (enrolling)
• Saint Elizabeth Healthcare — Edgewood, Kentucky, United States (enrolling)
• University of Michigan Health System - University Hospital — Ann Arbor, Michigan, United States (enrolling)
• Corewell Health — Grand Rapids, Michigan, United States (enrolling)
• Saint Joseph Mercy Ann Arbor — Ypsilanti, Michigan, United States (enrolling)
• M Health Fairview Clinic — Edina, Minnesota, United States (enrolling)
• CentraCare Heart & Vascular Center MN - Saint Cloud Hospital — Saint Cloud, Minnesota, United States (enrolling)
• Saint Lukes Mid America Heart Institute — Kansas City, Missouri, United States (enrolling)
• The University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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