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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 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.

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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).

Conditions Studied

Peripheral Arterial Disease Superficial Femoral Artery Stenosis

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

FieldValue
Enrollment Target 300 participants
Start Date 2022-12-01
Est. Completion 2030-12-01
Phase NA

Sponsor

M.A. Med Alliance S.A.

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05132361

The ClinicalTrials.gov registry entry for NCT05132361 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,202-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (93% lower). The listed sponsor is M.A. Med Alliance S.A., which has 4 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.