SELUTION4BTK Trial
Public ClinicalTrials.gov record NCT05055297. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Study identification
- NCT ID
- NCT05055297
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Lead sponsor
- M.A. Med Alliance S.A.
- Industry
- Enrollment
- 376 participants
Conditions and interventions
Conditions
Interventions
- Plain (Uncoated) Balloon Angioplasty (PTA) Device
- SELUTION SLR™ DEB 014 Device
Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 18, 2022
- Primary completion
- May 31, 2027
- Completion
- Jul 29, 2032
- Last update posted
- Apr 27, 2026
2022 – 2032
United States locations
- U.S. sites
- 30
- U.S. states
- 18
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Chandler Regional Medical Center | Chandler | Arizona | 85297 | Recruiting |
| St. Bernards Medical Center | Jonesboro | Arkansas | 72401 | Recruiting |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | Terminated |
| St. Helena Hospital | St. Helena | California | 94574 | Terminated |
| Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center | Torrance | California | 90502 | Recruiting |
| ClinRé | Thornton | Colorado | 80023 | Terminated |
| Vascular Care Group | Darien | Connecticut | 06820 | Recruiting |
| Yale University | New Haven | Connecticut | 06519 | Recruiting |
| The Cardiac and Vascular Institute Research Foundation | Gainesville | Florida | 32605 | Recruiting |
| Palm Vascular Centers | Miami | Florida | 33141 | Recruiting |
| Guardian Research Organization, LLC | Winter Park | Florida | 32792 | Recruiting |
| Cardiovascular Consultants of South Georgia | Thomasville | Georgia | 31792 | Terminated |
| Rush University Medical Center | Chicago | Illinois | 60612 | Recruiting |
| Advocate Lutheran General Hospital | Park Ridge | Illinois | 60068 | Recruiting |
| Cardiovascular Institute of the South | Gray | Louisiana | 70359 | Recruiting |
| MedStar Health Research Institute | Hyattsville | Maryland | 20782 | Recruiting |
| Beth Israel Medical Center | Boston | Massachusetts | 02215 | Recruiting |
| University of Massachusetts Medical Center | Worcester | Massachusetts | 01655 | Recruiting |
| Sorin Medical Group | New York | New York | 10005 | Recruiting |
| NC Heart and Vascular Research, LLC | Raleigh | North Carolina | 27607 | Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Recruiting |
| Hightower Clinical Research | Oklahoma City | Oklahoma | 73134 | Recruiting |
| Miriam Hospital | Providence | Rhode Island | 02906 | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | Recruiting |
| Tennessee Center for Clinical Trials | Tullahoma | Tennessee | 37388 | Suspended |
| El Paso Cardiology | El Paso | Texas | 79912 | Recruiting |
| Baylor College of Medicine | Houston | Texas | 77030 | Recruiting |
| Texas Cardiac and Vascular Institute San Antonio | San Antonio | Texas | 78229 | Recruiting |
| Christus Health | Tyler | Texas | 75702 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05055297, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 27, 2026 · Synced Apr 29, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05055297 live on ClinicalTrials.gov.