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SELUTION4BTK Trial

NCT05055297 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2026-04-28

No results posted yet for this 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

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

Interventions

DEVICE

SELUTION SLR™ DEB 014

a non-surgical procedure that uses a catheter to inflate a drug-eluting balloon to open up peripheral below-the-knee arteries that have been narrowed by chronic limb-threatening ischemia

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 peripheral below-the-knee arteries that have been narrowed by chronic limb-threatening ischemia

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
2022-05-19
Primary Completion
2027-06-01
Completion
2032-07-30
FDA Device
Yes

Countries

  • United States
  • Austria
  • France
  • Germany
  • Hong Kong
  • Italy
  • Netherlands
  • New Zealand
  • Singapore
  • Switzerland

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 NCT05055297 on ClinicalTrials.gov