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

IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Donald E. Cutlip MD , Roxana Mehran MD , Gheorghe Doros PhD , Vladimir Kaplinskiy MD , Jane Lee PhD , Luke Zheng BS , Milan Kausik MD , Eric Osborn MD, PhD , Ron Waksman MD
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引用次数: 0

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.
评估SELUTION SLR 014药物洗脱球囊治疗支架内再狭窄的安全性和有效性的前瞻性随机单盲多中心研究:理论基础和设计。
背景:重复药物洗脱支架在预防支架内再狭窄(ISR)复发方面优于球囊血管成形术,但存在多层支架的潜在缺点。西罗莫司药物洗脱球囊作为替代方案的安全性和有效性尚未得到评估。研究设计和方法:SELUTION4ISR试验是一项前瞻性、多中心、单盲、随机对照试验。共有418名受试者使用裸金属或药物洗脱支架(DES) ISR,在目标病变处进行最多2次支架手术,病变长度试验注册:该试验在Clinicaltrials.gov注册(NCT04280029)。目前状态:试验于2024年7月完成入组。结论:SELUTION4ISR研究将在一项前瞻性、随机、国际、多中心试验中评估SLR DEB治疗冠状动脉ISR的安全性和有效性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
American heart journal
American heart journal 医学-心血管系统
CiteScore
8.20
自引率
2.10%
发文量
214
审稿时长
38 days
期刊介绍: The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.
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