RecruitingCoronary Artery Disease

Prevail Global Study

Eligible age

18+ yrs

Accepts

All genders

Locations

28 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

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

Sponsor: Medtronic Vascular

✓ ≥ 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

✕ 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)