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SELUTION4BTK Trial
NCT05055297 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DEVICE SELUTION SLR™ DEB 014
- DEVICE Plain (Uncoated) Balloon Angioplasty (PTA)
Study Locations (20)
Florida
- The Cardiac and Vascular Institute Research Foundation — Gainesville
- Palm Vascular Centers — Miami
- Guardian Research Organization, LLC — Winter Park
Arkansas
- St. Bernards Medical Center — Jonesboro
- Arkansas Heart Hospital — Little Rock
California
- St. Helena Hospital — St. Helena
- Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center — Torrance
Connecticut
- Vascular Care Group — Darien
- Yale University — New Haven
Illinois
- Rush University Medical Center — Chicago
- Advocate Lutheran General Hospital — Park Ridge
Massachusetts
- Beth Israel Medical Center — Boston
- University of Massachusetts Medical Center — Worcester
Arizona
- Chandler Regional Medical Center — Chandler
Colorado
- ClinRé — Thornton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 376 participants |
| Start Date | 2022-05-19 |
| Est. Completion | 2032-07-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05055297
The ClinicalTrials.gov registry entry for NCT05055297 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 376 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.A. Med Alliance S.A., which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 2 interventions — of which SELUTION SLR™ DEB 014 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05055297 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, Arkansas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05055297 about?
NCT05055297 is a clinical study titled "SELUTION4BTK Trial". 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.
What is the current status of trial NCT05055297?
This trial is currently recruiting. It is a NA study. The enrollment target is 376 participants. The study started on 2022-05-19. Estimated completion is 2032-07-30.
What conditions does trial NCT05055297 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05055297?
The interventions under investigation include: SELUTION SLR™ DEB 014 (DEVICE), Plain (Uncoated) Balloon Angioplasty (PTA) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05055297?
This trial is sponsored by M.A. Med Alliance S.A., which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05055297 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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