SELUTION4BTK Trial
Recruiting now · Not applicable
Conditions studied: Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities
In brief
This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients.
Key facts
- Study ID
- NCT05055297
- Run by
- M.A. Med Alliance S.A.
- People needed
- 376
- Starts
- 2022-05-19
- Expected to finish
- 2032-07-30
- Last updated by the study team
- 2026-04-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Krankenhaus Buchholz — Buchholz, Germany (enrolling)
- St. Bernards Medical Center — Jonesboro, Arkansas, United States (enrolling)
- Queen Mary Hospital — Hong Kong, Pok Fu Lam, Hong Kong (enrolling)
- The Chinese University of Hong Kong — Hong Kong, Shatin, Hong Kong (enrolling)
- Ospedale Pederzoli — Peschiera del Garda, Verona, Italy (enrolling)
- UGC - Maria Cecilia Hospital — Cotignola, Italy (enrolling)
- St. Antonius Hospital — Nieuwegein, Netherlands (enrolling)
- Auckland City Hospital — Auckland, New Zealand (enrolling)
- Singapore General Hospital — Singapore, Singapore (enrolling)
- Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center — Torrance, California, United States (enrolling)
- Vascular Care Group — Darien, Connecticut, United States (enrolling)
- Yale University — New Haven, Connecticut, United States (enrolling)
- The Cardiac and Vascular Institute Research Foundation — Gainesville, Florida, United States (enrolling)
- Palm Vascular Centers — Miami, Florida, United States (enrolling)
- Guardian Research Organization, LLC — Winter Park, Florida, United States (enrolling)
- Rush University Medical Center — Chicago, Illinois, United States (enrolling)
- Advocate Lutheran General Hospital — Park Ridge, Illinois, United States (enrolling)
- Cardiovascular Institute of the South — Gray, Louisiana, United States (enrolling)
- MedStar Health Research Institute — Hyattsville, Maryland, United States (enrolling)
- Beth Israel Medical Center — Boston, Massachusetts, United States (enrolling)
- University of Massachusetts Medical Center — Worcester, Massachusetts, United States (enrolling)
- Sorin Medical Group — New York, New York, United States (enrolling)
- NC Heart and Vascular Research, LLC — Raleigh, North Carolina, United States (enrolling)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
- Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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