14146SELUTION-SLR-NCT04280029OpenSELUTION SLR™ 014 ISR:
A 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
Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial.
Subjects with previous bare-metal or drug-eluting coronary stent will be randomized 1:1 to treatment with either the SELUTION SLR™ DEB or SOC to include contemporary DES (zotarolimus-eluting stents and everolimus-eluting stents only) or non-DEB BA. A maximum of 418 randomized subjects will be included. Subjects will be followed for 5 years post-intervention. Primary endpoint will be target lesion failure (TLF) determined at 12-month clinical follow-up.NCT04280029IndustrialAdultTreatmentDevice: SELUTION SLR™ DEB
Device: ControlDiseases Of The Circulatory SystemThis study investigates the following conditions or diseases: Coronary RestenosisBen-Dor, ItsikMedstar Washington Hospital Center : Michelle SinghMCRN - Wash Interventional- 15701Michelle SinghMichelle Singhmichelle.singh@medstar.net
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