The SIR-POBA Bypass Trial

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06056193

Enrollment

Registered

2023-09-28

Start date

2023-09-20

Completion date

2027-10-01

Last updated

2025-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Autologous Vein Bypass, Endovascular Revascularization

Brief 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.

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.

Interventions

PROCEDUREBalloon Angioplasty

Revascularisation procedures will be performed according to randomised list

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026