SELUTION SLR™ 014 In-stent Restenosis

Brief Summary

Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial. Subjects with previous bare-metal stent (BMS) or Drug-Eluting Stent (DES) and qualifying evidence for In-stent Restenosis (ISR) will be screened per the protocol inclusion and exclusion criteria. Eligible subjects will be randomized 1:1 to treatment with either the SELUTION SLR 014 DEB or Standard of Care (SOC) to include contemporary DES (zotarolimus-eluting stents \[ZES\] and everolimus-eluting stents \[EES\] only) or Balloon Angioplasty (BA). A maximum of 20% of patients randomized to SOC will be treated with BA. The primary endpoint will be Target Lesion Failure (TLF) at 12-months in the SOC group vs. the SELUTION SLR 014 DEB in all patients.