🏛️ Verified NIH Record • Updated 2026-01-09

SELUTION4SFA Trial (NCT05132361)

A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Efficacy of the SELUTION SLR™ 018 Drug Eluting Balloon in the Treatment of Subjects With Femoropopliteal Artery Lesions

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: M.A. Med Alliance S.A.

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

This study aims to demonstrate the safety and efficacy of the SELUTION SLR™ 018 DEB compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).

Who can join: Review the eligibility criteria below.

Location: Arkansas Heart Hospital — Little Rock, Arkansas

Age range: 18 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (38 Sites)

Showing the first 25 of 38 sites.

  • Arkansas Heart Hospital — Little Rock, Arkansas
  • Mission Cardiovascular Research Institute — Fremont, California
  • St. Helena Hospital — St. Helena, California
  • ClinRé — Thornton, Colorado
  • Vascular Care Group — Darien, Connecticut
  • Manatee Memorial Hospital — Bradenton, Florida
  • The Cardiac and Vascular Institute Research Foundation — Gainesville, Florida
  • Memorial Healthcare System — Hollywood, Florida
  • First Coast Cardiovascular Institute — Jacksonville, Florida
  • Palm Vascular Centers — Miami Beach, Florida
  • Guardian Research Organization, LLC — Winter Park, Florida
  • Emory University Hospital — Atlanta, Georgia
  • Cardiovascular Consultants of South Georgia — Thomasville, Georgia
  • Heart Care Centers Research Foundation — Palos Park, Illinois
  • Advocate Lutheran General Hospital — Park Ridge, Illinois
  • Cardiovascular Institute of the South — Gray, Louisiana
  • MedStar Health Research Institute — Hyattsville, Maryland
  • Mercy Hospital — St Louis, Missouri
  • Holy Name Medical Center — Teaneck, New Jersey
  • James J. Peters VA Medical Center — The Bronx, New York
  • NC Heart and Vascular Research, LLC — Raleigh, North Carolina
  • Cleveland Clinic — Cleveland, Ohio
  • Miriam Hospital — Providence, Rhode Island
  • Tennessee Center for Clinical Trials — Tullahoma, Tennessee
  • El Paso Cardiology — El Paso, Texas

💰 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 § 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.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗