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SELUTION4SFA Trial

NCT05132361 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-01-12

No results posted yet for this 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

  • Peripheral Arterial Disease
  • Superficial Femoral Artery Stenosis

Interventions

DEVICE

SELUTION SLR™ 018 DEB

a non-surgical procedure that uses a catheter to inflate a drug-eluting balloon to open up above the-knee arteries that have been narrowed due to peripheral arterial disease.

DEVICE

Plain (Uncoated) Balloon Angioplasty (PTA)

a non-surgical procedure that uses a catheter to inflate a commercially available, non-drug-eluting balloon to open up above the-knee arteries that have been narrowed due to peripheral arterial disease.

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Cordis US Corp.

    collaborator INDUSTRY

  • M.A. Med Alliance S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2026-06-24
Completion
2030-12-01
FDA Device
Yes

Countries

  • United States
  • Austria
  • Germany
  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05132361 on ClinicalTrials.gov