Prospective randomized single-blind multicenter study to assess the safety and effectiveness of the SELUTION SLR 014 drug eluting balloon in the treatment of subjects with in-stent restenosis: Rationale and design
Study context
- Population
- Subjects with bare metal or drug-eluting stent (DES) in-stent restenosis (ISR) with up to 2 previous stent procedures at the target lesion, lesion length <26 mm and reference diameter ≥2.0 mm - ≤4.5 mmplanned randomization
- Participants
- 418 subjects
- Planned comparison
- Noninferiority of the SLR DEB to standard of care (SOC) in the overall cohort, followed by noninferiority then superiority of the SLR DEB to DES in the cohort with only 1 previous stent at the target lesion
- Primary endpoint
- target lesion failure, defined as cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularization
- Follow-up
- 12 months
Methodological detailssubset with planned angiographic and optical coherence tomography follow-up, international
- Subset with planned angiographic and optical coherence tomography follow-up
- International
No results yet. This paper sets out the design of a trial; its results are to come.
Further findings
Enrollment status
- The trial completed enrollment in July 2024.
Original publication
Prospective randomized single-blind multicenter study to assess the safety and effectiveness of the SELUTION SLR 014 drug eluting balloon in the treatment of subjects with in-stent restenosis: Rationale and design. Am Heart J. Published 12 February 2025. doi:10.
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