SELUTION SLR™ 014 In-stent Restenosis
Running, not enrolling · Not applicable
Conditions studied: Coronary Restenosis
In brief
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.
Key facts
- Study ID
- NCT04280029
- Run by
- M.A. Med Alliance S.A.
- People needed
- 418
- Starts
- 2020-07-06
- Expected to finish
- 2029-08-01
- Last updated by the study team
- 2025-12-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Loma Linda University — Loma Linda, California, United States
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- Harbor-UCLA Medical Center — Torrance, California, United States
- ClinRe 001-001 — Thornton, Colorado, United States
- MedStar Heart Institute — Washington D.C., District of Columbia, United States
- University of Florida Health — Jacksonville, Florida, United States
- Baptist Cardiac & Vascular Institute — Miami, Florida, United States
- Atlanta VA Medical Center — Atlanta, Georgia, United States
- Piedmont Heart Institute — Atlanta, Georgia, United States
- Ascension St Vincents Heart Center — Indianapolis, Indiana, United States
- Ascension Via Christi — Wichita, Kansas, United States
- University of Maryland — Baltimore, Maryland, United States
- Beth Israel Deaconess Medical Centre, Harvard Medical School — Boston, Massachusetts, United States
- Ascension Borgess Heart Institute — Kalamazoo, Michigan, United States
- Beaumont Hospital — Royal Oak, Michigan, United States
- Ascension St John Hospital — Southfield, Michigan, United States
- Minneapolis Heart Institute — Minneapolis, Minnesota, United States
- Manchester Catholic Medical Center — Manchester, New Hampshire, United States
- Morristown Medical Center — Morristown, New Jersey, United States
- Rutgers, Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
- Mount Sinai Hospital — New York, New York, United States
- St. Francis Hospital & Heart Center — Roslyn, New York, United States
- Moses H. Cone Memorial Hospital — Greensboro, North Carolina, United States
- NC Heart and Vascular Research, LLC — Raleigh, North Carolina, United States
- The Christ Hospital — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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