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NCT05132361 · ClinicalTrials.gov registry record · NA
SELUTION4SFA Trial
A NA study of Peripheral Arterial Disease and Superficial Femoral Artery Stenosis, sponsored by M.A. Med Alliance S.A..
- Active
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT05132361: Active NA study of Peripheral Arterial Disease and Superficial Femoral Artery Stenosis, sponsored by M.A. Med Alliance S.A..
NCT05132361 is a NA study of Peripheral Arterial Disease and Superficial Femoral Artery Stenosis that is active but no longer recruiting, run by M.A. Med Alliance S.A.. The registered enrollment target is 300 participants, below the 4,202-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05132361, a NA study of Peripheral Arterial Disease and Superficial Femoral Artery Stenosis, is active but no longer recruiting, sponsored by M.A. Med Alliance S.A..
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
Primary patency of the target lesion defined as freedom from ANY of the following adverse events: * Clinically driven target lesion revascularization (CD-TLR, defined as re-intervention of target lesion(s) due to recurrent, persistent, or worsening symptoms and angiographic restenosis (≥ 50% diameter stenosis) of target lesion by ACL measurement) OR * Restenosis as determined by core lab adjudicated duplex ultrasound peak systolic velocity ratio of \>2.4 or occlusion of the target lesion.
Conditions Studied
Interventions
- DEVICE Plain (Uncoated) Balloon Angioplasty (PTA)
- DEVICE SELUTION SLR™ 018 DEB
Study Locations (20)
Florida
- Manatee Memorial Hospital - Bradenton
- The Cardiac and Vascular Institute Research Foundation - Gainesville
- Memorial Healthcare System - Hollywood
- First Coast Cardiovascular Institute - Jacksonville
- Palm Vascular Centers - Miami Beach
- Guardian Research Organization, LLC - Winter Park
California
- Mission Cardiovascular Research Institute - Fremont
- St. Helena Hospital - St. Helena
Georgia
- Emory University Hospital - Atlanta
- Cardiovascular Consultants of South Georgia - Thomasville
Illinois
- Heart Care Centers Research Foundation - Palos Park
- Advocate Lutheran General Hospital - Park Ridge
Arkansas
- Arkansas Heart Hospital - Little Rock
Colorado
- ClinRé - Thornton
Connecticut
- Vascular Care Group - Darien
Louisiana
- Cardiovascular Institute of the South - Gray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2022-12-01 |
| Est. Completion | 2030-12-01 |
| Phase | NA |
What the registry record for NCT05132361 still lists
NCT05132361 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 4,202-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 2 interventions - of which Plain (Uncoated) Balloon Angioplasty (PTA) is the first listed.
NCT05132361 names 20 study sites across 12 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT05132361 about?
NCT05132361 is a clinical study titled "SELUTION4SFA Trial". 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).
What is the current status of trial NCT05132361?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2022-12-01. Estimated completion is 2030-12-01.
What conditions does trial NCT05132361 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease, Superficial Femoral Artery Stenosis.
What interventions are being tested in trial NCT05132361?
The interventions under investigation include: Plain (Uncoated) Balloon Angioplasty (PTA) (DEVICE), SELUTION SLR™ 018 DEB (DEVICE).
Who is sponsoring clinical trial NCT05132361?
This trial is sponsored by M.A. Med Alliance S.A., which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05132361 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05132361's enrollment target sits among peer trials
300 14th of 79 higher than 64 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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