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

ACTIVE NOT RECRUITING NA

SELUTION4SFA Trial

NCT05132361 · View on ClinicalTrials.gov ↗

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).

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.

35 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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.A. Med Alliance S.A., which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05132361 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05132361?

The interventions under investigation include: Plain (Uncoated) Balloon Angioplasty (PTA) (DEVICE), SELUTION SLR™ 018 DEB (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05132361?

This trial is sponsored by M.A. Med Alliance S.A., which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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