Status:
RECRUITING
Prevail Global Study
Lead Sponsor:
Medtronic Vascular
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
Detailed Description
The Prevail Global study is a prospective, premarket, interventional, multi-center, global, dual cohort clinical study enrolling subjects undergoing percutaneous coronary intervention for in-stent res...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
February 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2031
Estimated Enrollment :
1205 Patients enrolled
Trial Details
Trial ID
NCT06535854
Start Date
February 24 2025
End Date
February 1 2031
Last Update
October 24 2025
Active Locations (45)
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1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Huntsville Hospital
Huntsville, Alabama, United States, 35801
3
Carondelet Saint Marys
Tucson, Arizona, United States, 85745
4
John L McClellan Memorial Veterans Hospital
Little Rock, Arkansas, United States, 72205