Rationale and design of the prevail global trial program evaluating the prevail drug-coated balloon in patients with in-stent restenosis and de novo small vessel disease

Abstract

Background and Rationale

In-stent restenosis (ISR) remains the leading cause of treatment failure following percutaneous coronary intervention (PCI) with contemporary drug-eluting stents. Especially in small caliber coronary arteries, restenosis is common following PCI and represents a treatment challenge. Drug-coated balloons (DCB) are an attractive alternative to stents for treatment of both ISR and small vessel disease. The safety and efficacy of the Prevail DCB will be assessed for (1) the treatment of ISR and (2) de novo lesions in small vessels.

Trial Design

Prevail Global is a prospective, international, dual cohort clinical study enrolling (1) patients undergoing PCI for ISR in a randomized controlled trial (1:1) design comparing the Prevail DCB versus an FDA-approved DCB (Agent^TM, Boston Scientific Corporation, Natick MA), and (2) patients with de novo small vessel disease undergoing PCI with the Prevail DCB as part of a single-arm study compared with a historical control. The primary endpoint is target lesion failure, defined as a composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularization at 12 months post procedure. Patient follow-up is planned for 1 month, 6 months, and yearly through 5 years. Enrollment is expected to start in early 2025.

Conclusions

The Prevail Global study will directly assess the safety and efficacy of the Prevail DCB for the treatment of ISR and de novo small vessel lesions.

Trial Registration

Prevail Global, NCT06535854, is registered at https://clinicaltrials.gov/study/NCT06535854.