Prevail Global

Full Clinical Trial Name

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).

Clinical Trial

  • Heart and Vascular

Patient Type

Adult
Doctor(s) running this study
Shailendra Singh, MD
Location(s):
Call 610-402-9543
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Purpose

Medtronic Vascular, Inc. is sponsoring the Prevail Global study. The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail Drug-Coated Balloon (DCB). In the in-stent restenosis (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 drug eluting stent (DES) or bare metal stent (BMS) in native coronary arteries. In the de novo small vessel (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 percutaneous coronary intervention (PCI) for de novo lesions in small vessel disease.

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 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

Inclusion Criteria

Subject has documented stable or unstable angina, positive functional test, or non-ST elevation myocardial infarction which, in the judgment of the physician, is attributable to disease in a small coronary vessel or in-stent restenosis, and the subject is deemed an appropriate candidate for percutaneous coronary intervention (PCI), in accordance with the applicable guidelines on percutaneous coronary intervention. 

  • ≥ 18 years
  • Negative pregnancy test
  • Life expectancy >1 year

Learn more about the full clinical trial

Full description at clinicaltrials.gov

Doctor(s) running this study