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
- Dresden, Homburg, and Lahr, GermanySee the 3 sites
Where in Germany
- Herzzentrum Dresden GmbH UniversitätsklinikDresden, GermanyTaking people
- Universität Des SaarlandesHomburg, GermanyTaking people
- MediClin Herzzentrum Lahr / BadenLahr, GermanyTaking 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.