MedTrace Logo

The SIR-POBA Bypass Trial

NCT06056193 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-06-29

No results posted yet for this study

Summary

The goal of this clinical trial is to compare plain old balloon angioplasty with sirolimus-coated balloon angioplasty in patients with an infrainguinal venous bypass stenosis. The main question we aim to answer is, how patency is affected by each of the randomised treatment options.

Conditions

  • Peripheral Arterial Occlusive Disease
  • Bypass Complication
  • Femoropopliteal Artery Occlusion
  • Femoropopliteal Stenosis
  • Critical Limb-Threatening Ischemia
  • Claudication, Intermittent

Interventions

PROCEDURE

Balloon Angioplasty

Revascularisation procedures will be performed according to randomised list

Sponsors & Collaborators

  • MedAlliance Swiss Medical Technology

    collaborator UNKNOWN

  • Paracelsus Medical University

    lead OTHER

Principal Investigators

  • Manuela Pilz, MD PD FEBVS · Senior Physician

  • Klaus Linni, MD PD FEBVS · Head of Division of Vascular and Endovascular Surgery

  • Stephanie Rassam, MD · Resident Physician

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-20
Primary Completion
2025-10-01
Completion
2027-10-01

Countries

  • Austria

Study Locations

More Related Trials

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 NCT06056193 on ClinicalTrials.gov