The SIR-POBA Bypass Trial

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: Balloon Angioplasty


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autologous Vein Bypass, Endovascular Revascularization