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 - 08/03/25
, Roxana Mehran, MD c, Gheorghe Doros, PhD b, d, Vladimir Kaplinskiy, MD b, Jane Lee, PhD b, Luke Zheng, BS b, d, Milan Kausik, MD b, Eric Osborn, MD, PhD a, Ron Waksman, MD eHighlights |
• | Randomized multicenter clinical trial comparing a sirolimus eluting balloon with standard of care (including at least 80% drug-eluting stents and up to 20% balloon angioplasty) for treatment of in-stent restenosis with 1 or 2 layers of previous stents. |
• | The study will assess noninferiority of the sirolimus-eluting balloon with the current standard of care as the primary endpoint. |
• | In sequential testing the study will also assess noninferiority and then superiority of the sirolimus eluting balloon versus drug-eluting stents in patients with single previous layer of stent. |
ABSTRACT |
Background |
Repeat drug-eluting stenting is superior to balloon angioplasty for prevention of recurrent in-stent restenosis (ISR), but carries a potential disadvantage of multiple layers of stent. The safety and effectiveness of a sirolimus drug-eluting balloon as an alternative has not been assessed.
Study Design and Methods |
The SELUTION4ISR trial is a prospective, multicenter, single-blinded, randomized, controlled trial. A total of 418 subjects with bare metal or drug-eluting stent (DES) ISR with up to 2 previous stent procedures at the target lesion, lesion length <26 mm and reference diameter ≥2.0 mm - ≤4.5 mm will be randomized 1:1 to treatment with either the SELUTION SLR™ DEB (SLR DEB) or standard of care (SOC), which includes either repeat DES or balloon angioplasty without drug coating. A subset of subjects will undergo planned angiographic and optical coherence tomography follow-up. The primary endpoint will be target lesion failure, defined as cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularization at 12 months follow-up. The study will sequentially assess noninferiority of the SLR DEB to 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.
Trial Registration |
The trial is registered at Clinicaltrials.gov (NCT04280029).
Current Status |
The trial completed enrollment in July 2024.
Conclusion |
The SELUTION4ISR study will evaluate the safety and effectiveness of SLR DEB in a prospective, randomized, international, multicenter trial for treatment of coronary ISR.
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Vol 284
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