The SIR-POBA Bypass Trial

Paracelsus Medical University

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

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

Interventions

Balloon AngioplastyPROCEDURE

Revascularisation procedures will be performed according to randomised list

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

University Hospital of Salzburg, Paracelsus Medical University

Salzburg, Salzburg, Austria

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Data from ClinicalTrials.gov

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