Radar des Essais Cliniques

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.