Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Conditions Studied

Peripheral Arterial Disease Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities

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

FieldValue
Enrollment Target 376 participants
Start Date 2022-05-19
Est. Completion 2032-07-30
Phase NA

Sponsor

M.A. Med Alliance S.A.

4 total trials

Interested in This Trial?

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, categorized as NA. The registered enrollment target is 376 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,201-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (91% 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 SELUTION SLR™ DEB 014 is the first listed.

NCT05055297 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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

Similar trials for Peripheral Arterial Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Peripheral Arterial Disease

All registered trials for this condition

Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities

All registered trials for this condition

Arizona

All trials with a study site in Arizona

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
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.