Prevail Global
Research type
Research Study
Full title
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)
IRAS ID
348473
Contact name
Azfar G. Zaman
Contact email
Sponsor organisation
Medtronic Vascular, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 2 months, 1 days
Research summary
The purpose of this global study is to evaluate the clinical safety and efficacy of the Prevail Drug-Coated Balloon (DCB) in 1) the treatment of in-stent restenosis (ISR) which is characterized by narrowing of arteries previously treated with stents and, 2) in new narrowing of arteries in small vessels (de novo small vessel disease, DNSV).
The Prevail DCB is a small balloon that contains medication on it. The balloon is at the tip of a catheter used to get to the arteries in the heart. The medication is designed to reduce the re-occurrence of narrowed arteries. The Prevail DCB used for this study is considered an investigational device. A version of this product was approved for use in July 2020.
The patients in the study that will be treated for ISR, will receive either the Prevail DCB, or competitor product, Agent DCB which is already approved for use for patients who need a procedure to open narrow coronary arteries. The assignment of which DCB a patient will get is determined by randomisation in a 1:1 ratio.
The patients in the study that will be treated for DNSV will only be treated with the Prevail DCB. Results from this cohort will be compared to historical results from Medtronic clinical studies using coronary stents.
Patients will be followed up for 5 years after the procedure. The overall study is expected to last about 6 years, recruiting approximately 1205 patients at about 65 sites worldwide.
REC name
London - Surrey Research Ethics Committee
REC reference
25/LO/0113
Date of REC Opinion
11 Feb 2025
REC opinion
Favourable Opinion