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).

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

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 restenosis (ISR Cohort) in a randomized controlled study of the Prevail Drug-Coated Balloon, and subjects undergoing percutaneous coronary intervention of the Prevail Drug-Coated Balloon for de novo lesions in small vessel disease (DNSV Cohort) in a single arm prospectively enrolled study.

In the ISR Cohort this will be accomplished by randomizing subjects to either a Prevail DCB arm or an Agent DCB arm to compare results of the treatment of ISR with coronary lesions previously treated with DES or BMS in native coronary arteries. In the DNSV Cohort this will be accomplished through collection of data to compare results of the Prevail DCB to a DES historical control in subjects undergoing PCI for de novo lesions in small vessel disease.

Subjects will be enrolled at approximately 65 study sites; the same study sites will be used for enrollment of both cohorts. The enrollment period is anticipated to be approximately 12 months. Subjects will remain in the study with follow-up clinical assessments through 5 years, study exit, or death, whichever comes first.

Inclusion Criteria:

• ≥ 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 Criteria:

• 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