NCT06056193

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• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Paracelsus Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Balloon Angioplasty	Revascularisation procedures will be performed according to randomised list

Timeline

• Start date: 2023-09-20
• Primary completion: 2025-10-01
• Completion: 2027-10-01
• First posted: 2023-09-28
• Last updated: 2025-06-29

Locations

1 site across 1 country: Austria