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NCT05055297 · ClinicalTrials.gov registry record · NA
SELUTION4BTK Trial
A NA study of Peripheral Arterial Disease and Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities, sponsored by M.A. Med Alliance S.A..
- Recruiting
- Registry status
- NA
- Development phase
- 376
- Enrollment target
- 20
- Study locations
NCT05055297: Recruiting NA study of Peripheral Arterial Disease and Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities, sponsored by M.A. Med Alliance S.A..
NCT05055297 is a NA study of Peripheral Arterial Disease and Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities that is actively recruiting participants, run by M.A. Med Alliance S.A.. The registered enrollment target is 376 participants, below the 4,201-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05055297, a NA study of Peripheral Arterial Disease and Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities, is actively recruiting participants, sponsored by M.A. Med Alliance S.A..
- RECRUITING
- Registry status
- NA
- Development phase
- 376 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Hierarchical composite efficacy endpoint determined by pair-wise comparisons among all subjects (Win Ratio method) according to the following pre-specified hierarchy of adverse outcomes: * Major (above-the-ankle) amputation * CD-TLR * Target lesion occlusion by angiography (if angiography is not available, the decision will be made on a secondary modality, in order of preference: computed tomography angiogram \[CTA\], magnetic resonance angiography \[MRA\] or DUS) * Transverse View Area Loss (T
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 |
What NCT05055297 shows while recruiting
NCT05055297 is an interventional study that assigns participants to a tested intervention. The registered 376 participants enrollment target is mid-sized for trials with a published cap, below the 4,201-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (91% lower).
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.
NCT05055297 names 20 study sites across 13 states, led by Florida, Arkansas, California.
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.
What interventions are being tested in trial NCT05055297?
The interventions under investigation include: SELUTION SLR™ DEB 014 (DEVICE), Plain (Uncoated) Balloon Angioplasty (PTA) (DEVICE).
Who is sponsoring clinical trial NCT05055297?
This trial is sponsored by M.A. Med Alliance S.A., which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05055297's enrollment target sits among peer trials
376 11th of 79 higher than 69 of 79 other Peripheral Arterial Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Arterial Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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