Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial.

Subjects with previous bare-metal stent (BMS) or DES and qualifying evidence for 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 SOC to include contemporary DES (zotarolimus-eluting stents \[ZES\] and everolimus-eluting stents \[EES\] only) or 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.

Conditions

  • Coronary Restenosis

Intervention

  • SELUTION SLR™ DEB
  • Control

Principal Investigator

  • Prasad, Vinoy

Sponsor

  • MedAlliance

*The source of data for this particular study is "ClinicalTrials.gov" and was last updated on 05/16/2024. Loma Linda University does not make any warranties, expressed or implied, with respect to such data, and, furthermore, assumes no liability for any party's use, or the results of such use of the data.

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