The SIR-POBA Bypass Trial

Paracelsus Medical University (PMU)

Status

Withdrawn

Conditions

Claudication, Intermittent

Peripheral Arterial Occlusive Disease

Bypass Complication

Femoropopliteal Stenosis

Critical Limb-Threatening Ischemia

Femoropopliteal Artery Occlusion

Treatments

Procedure: Balloon Angioplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT06056193

1036/2023

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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).