MedTrace Logo

Trial to Assess the Safety and Efficacy of Sirolimus-Coated Balloon vs. Uncoated Standard Angioplasty for the Treatment of Below-the-knee Peripheral Arterial Disease

NCT04772300 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2025-12-26

No results posted yet for this study

Summary

This study is a prospective, interventional, multicenter 1:1 randomized trial.

The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with POBA (control device) in patients with advanced infrapopliteal artery disease.

Conditions

Interventions

COMBINATION_PRODUCT

Percutaneous Transluminal Angioplasty (PTA) MagicTouch Sirolimus Coated PTA Balloon Catheter

PTA with an sirolimus drug-coated balloon catheter (SRL-DCB) in the infrapopliteal artery

DEVICE

Percutaneous Transluminal Angioplasty (PTA) with non-coated balloon catheter (POBA)

PTA with an non-coated balloon catheter (POBA) in the infrapopliteal artery

Sponsors & Collaborators

  • Concept Medical Inc.

    collaborator INDUSTRY

  • Vascuscience

    collaborator UNKNOWN

  • CoreLab Black Forest

    collaborator UNKNOWN

  • Center for Clinical Studies Jena

    collaborator UNKNOWN

  • Jena University Hospital

    lead OTHER

Principal Investigators

  • Ulf Teichgraeber, Prof. Dr. · University Hospital Jena, Institute of Radiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-10
Primary Completion
2026-04-17
Completion
2028-11-17

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT04772300 on ClinicalTrials.gov