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WITHDRAWNNANCT06056193

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...

Lead sponsor: Paracelsus Medical University•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Paracelsus Medical University

Collaborators

MedAlliance Swiss Medical Technology

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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).

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 29, 2025Terms

Trial snapshot

StatusWITHDRAWN

PhaseNA

Enrollment—

Start dateSep 2023

Last updatedJun 29, 2025

Condition

Peripheral Arterial Occlusive Disease Bypass Complication Femoropopliteal Artery Occlusion Femoropopliteal Stenosis Critical Limb-Threatening Ischemia+1 more

Locations shown

University Hospital of Salzburg, Paracelsus Medical University

Salzburg, Salzburg

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2025Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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