πŸ›οΈ Verified NIH Record β€’ Updated 2026-04-27

SELUTION4BTK Trial (NCT05055297)

🟒 Recruiting Observational / Diagnostic βš™οΈ Medical Device Protocol Sponsor: M.A. Med Alliance S.A.

🩺 Plain-English Summary (8th-Grade Level)

This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLRβ„’ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients.

Who can join: Review the eligibility criteria below.

Location: Chandler Regional Medical Center β€” Chandler, Arizona

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (48 Sites)

  • Chandler Regional Medical Center β€” Chandler, Arizona
  • St. Bernards Medical Center β€” Jonesboro, Arkansas
  • Arkansas Heart Hospital β€” Little Rock, Arkansas
  • St. Helena Hospital β€” St. Helena, California
  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center β€” Torrance, California
  • ClinRΓ© β€” Thornton, Colorado
  • Vascular Care Group β€” Darien, Connecticut
  • Yale University β€” New Haven, Connecticut
  • The Cardiac and Vascular Institute Research Foundation β€” Gainesville, Florida
  • Palm Vascular Centers β€” Miami, Florida
  • Guardian Research Organization, LLC β€” Winter Park, Florida
  • Cardiovascular Consultants of South Georgia β€” Thomasville, Georgia
  • Rush University Medical Center β€” Chicago, Illinois
  • Advocate Lutheran General Hospital β€” Park Ridge, Illinois
  • Cardiovascular Institute of the South β€” Gray, Louisiana
  • MedStar Health Research Institute β€” Hyattsville, Maryland
  • Beth Israel Medical Center β€” Boston, Massachusetts
  • University of Massachusetts Medical Center β€” Worcester, Massachusetts
  • Sorin Medical Group β€” New York, New York
  • NC Heart and Vascular Research, LLC β€” Raleigh, North Carolina
  • University Hospitals Cleveland Medical Center β€” Cleveland, Ohio
  • Cleveland Clinic β€” Cleveland, Ohio
  • Hightower Clinical Research β€” Oklahoma City, Oklahoma
  • Miriam Hospital β€” Providence, Rhode Island
  • Vanderbilt University Medical Center β€” Nashville, Tennessee

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
πŸ›οΈ View Official NIH Record β†—