SELUTION4BTK Trial (NCT05055297)
SELUTION SLR™ 014 BTK: A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Below-the-Knee (BTK) Atherosclerotic Disease in Patients With Chronic Limb Threatening Ischemia (CLTI)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Chandler Regional Medical Center — Chandler, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (48 Sites)
Showing the first 25 of 48 sites.
- Chandler Regional Medical Center — Chandler, Arizona
- St. Bernards Medical Center — Jonesboro, Arkansas
- Arkansas Heart Hospital — Little Rock, Arkansas
- St. Helena Hospital — St. Helena, California
- Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center — Torrance, California
- ClinRé — Thornton, Colorado
- Vascular Care Group — Darien, Connecticut
- Yale University — New Haven, Connecticut
- The Cardiac and Vascular Institute Research Foundation — Gainesville, Florida
- Palm Vascular Centers — Miami, Florida
- Guardian Research Organization, LLC — Winter Park, Florida
- Cardiovascular Consultants of South Georgia — Thomasville, Georgia
- Rush University Medical Center — Chicago, Illinois
- Advocate Lutheran General Hospital — Park Ridge, Illinois
- Cardiovascular Institute of the South — Gray, Louisiana
- MedStar Health Research Institute — Hyattsville, Maryland
- Beth Israel Medical Center — Boston, Massachusetts
- University of Massachusetts Medical Center — Worcester, Massachusetts
- Sorin Medical Group — New York, New York
- NC Heart and Vascular Research, LLC — Raleigh, North Carolina
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio
- Hightower Clinical Research — Oklahoma City, Oklahoma
- Miriam Hospital — Providence, Rhode Island
- Vanderbilt University Medical Center — Nashville, Tennessee
📞 Contact the Study Coordinator
Phone: (484) 680-5857
Email: kara.piscani@cordis.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
More studies in Peripheral Arterial Disease
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- A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND) — Birmingham, Alabama
- Shortwave Diathermy In-home Treatment for Indianapolis VA-only Patients Diagnosed With Peripheral Artery Disease and Peripheral Neuropathy — Indianapolis, Indiana
- FGF-1 for Intramuscular Injection for the Treatment of Peripheral Arterial Disease — Chicago, Illinois
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.