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Sirolimus- vs. Paclitaxel-Drug Coated Ballons in Patients With Peripheral Artery Disease

NCT04475783 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2025-12-26

No results posted yet for this study

Summary

This study is a prospective, interventional, multi-center 1:1 randomized non-inferiority trial.

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

Conditions

Interventions

COMBINATION_PRODUCT

Percutaneous Transluminal Angioplasty (PTA)

PTA with an drug-coated balloon catheter (DCB) in the femoropopliteal artery

Sponsors & Collaborators

  • Concept Medical Inc.

    collaborator INDUSTRY

  • Vascuscience

    collaborator UNKNOWN

  • CoreLab Black Forest

    collaborator UNKNOWN

  • Center for Clinical Studies, Jena University Hospital

    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
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-13
Primary Completion
2023-12-31
Completion
2027-12-31

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 NCT04475783 on ClinicalTrials.gov