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
Study context
- Population
- Patients undergoing percutaneous coronary intervention (PCI) for in-stent restenosis (ISR), and patients with de novo small vessel disease undergoing PCI
- Planned comparison
- The Prevail drug-coated balloons (DCB) versus an FDA-approved DCB
- Primary endpoint
- target lesion failure, defined as a composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularization
- Follow-up
- 12 months post procedure
Methodological detailsrandomized controlled trial (1:1) design (ISR cohort), single-arm study compared with a historical control (de novo small vessel cohort)
- Randomized controlled trial (1:1) design (ISR cohort)
- Single-arm study compared with a historical control (de novo small vessel cohort)
No results yet. This paper sets out the design of a trial; its results are to come.
Further findings
Study conduct
- Patient follow-up is planned for 1 month, 6 months, and yearly through 5 years
- Enrollment is expected to start in early 2025
Original publication
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. Am Heart J. Published 23 January 2025. doi:10.
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