The SIR-POBA Bypass Trial

Not Applicable

Active, not recruiting

• Conditions: Bypass Complication; Femoropopliteal Artery Occlusion; Peripheral Arterial Occlusive Disease; Claudication, Intermittent; Femoropopliteal Stenosis; Critical Limb-Threatening Ischemia
• Interventions: Procedure: Balloon Angioplasty

• Registration Number: NCT06056193
• Lead Sponsor: Paracelsus Medical University

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.

Study Timeline

• Status Verified: 2023-09
• Study Start: 2023-09-20
• Study First Submitted: 2023-09-20
• Study First Submitted QC: 2023-09-20
• Last Update Submitted: 2023-09-20
• Study First Posted: 2023-09-28
• Last Update Posted: 2023-09-28
• Primary Completion: 2025-10-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plain Balloon Angioplasty	Balloon Angioplasty	Plain Balloon Angioplasty will be used to treat lesions
Sirolimus-coated Balloon Angioplasty	Balloon Angioplasty	Sirolimus-coated Balloon Angioplasty will be used to treat lesions after preparing vessel with plain balloon angioplasty

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospital of Salzburg, Paracelsus Medical University; 🇦🇹 Salzburg, Austria