The SIR-POBA Bypass Trial

June 25, 2025 updated by: Manuela Pilz, Paracelsus Medical University

SIRrolimus-coated Versus Plain Old Balloon Angioplasty (POBA) in Lower Extremity Autologous Venous Bypass Stenosis - The SIR-POBA Bypass Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This clinical trial will be conducted at our Division of Vascular Surgery and Endovascular Surgery at the University Hospital of Salzburg. Patients will be randomized into one of the two treatment options (plain old ballon angioplasty versus sirolimus coated balloon angioplasty). The recruitment phase is calculated for two years with a planned follow-up of 2 years. Follow-up data will be collected to answer the endpoints and will include all available follow-ups to monitor the bypass up to 2 years after the procedure. Typically, follow-up visits will be conducted at 6 weeks, 3 months, 6 months, 12 months, and 24 months after the procedure.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • University Hospital of Salzburg, Paracelsus Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Age at least 18 years
  • Informed consent with signature
  • Rutherford category 2 or 3 (in terms of lifestyle-limiting moderate or severe claudication symptomatology) or chronic critical ischemia (Rutherford 4-6)
  • Venous bypass stenosis requiring intervention
  • Confirmed inflow
  • At least 1 crural outflow vessel

Exclusion Criteria:

  • Pregnant or lactating women
  • Active infection or sepsis
  • Patients currently participating in another clinical trial
  • Unconfirmed inflow
  • Intolerance to sirolimus
  • Coagulopathy
  • Radiotherapy
  • Patients on immunosuppressive therapy
  • Non-dialysis renal insufficiency (eGFR < 45 ml/min/1.73m2)
  • Use of potent CYP3A4 and/or P-gp inhibitors (such as ketoconazole, Voriconazole, itraconazole, erythromycin, telithromycin, or clarithromycin) or strong CYP3A4 and/or P-gp inducers (such as rifampin or rifabutin).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Plain Balloon Angioplasty
Plain Balloon Angioplasty will be used to treat lesions
Procedure: Balloon Angioplasty
Revascularisation procedures will be performed according to randomised list
Other Names:
  • Endovascular Revascularization
Active Comparator: Sirolimus-coated Balloon Angioplasty
Sirolimus-coated Balloon Angioplasty will be used to treat lesions after preparing vessel with plain balloon angioplasty
Procedure: Balloon Angioplasty
Revascularisation procedures will be performed according to randomised list
Other Names:
  • Endovascular Revascularization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Primary Lesion Target Patency of the venous bypass stenosis
Time Frame: 2 years
The incidence of patency will be analysed after reopening the stenosis of the venous bypass.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paracelsus Medical University

Collaborators

MedAlliance Swiss Medical Technology

Investigators

  • Study Chair: Stephanie Rassam, MD, Resident Physician
  • Principal Investigator: Manuela Pilz, MD PD FEBVS, Senior Physician
  • Study Director: Klaus Linni, MD PD FEBVS, Head of Division of Vascular and Endovascular Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

June 29, 2025

Last Update Submitted That Met QC Criteria

June 25, 2025

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1036/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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