Prevail Global Study
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).
Medtronic Vascular
1,205 participants
Feb 24, 2025
INTERVENTIONAL
Conditions
Summary
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
Eligibility
Inclusion Criteria5
- ≥ 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 Criteria13
- 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
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Interventions
The Prevail Paclitaxel-coated PTCA Balloon Catheter is intended for percutaneous transluminal coronary angioplasty (PTCA) in the coronary arteries with a vessel diameter from 2.00 mm to 4.00 mm to treat in-stent restenosis (ISR) and to treat de novo lesions in small vessel disease.
The Agent Paclitaxel-coated PTCA Balloon Catheter is intended for percutaneous transluminal coronary angioplasty (PTCA) in the coronary arteries with a vessel diameter from 2.00 mm to 4.00 mm to treat in-stent restenosis (ISR).
Locations(51)
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NCT06535854