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)
Objective
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.
Eligibility
- ≥ 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
NCT ID
NCT06535854
