The SIR-POBA Bypass Trial

Peripheral Arterial Occlusive Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06056193
• Other study ID #: 1036/2023
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 20, 2023
• Est. completion date: October 1, 2027

Study information

• Verified date: September 2023
• Source: Paracelsus Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: October 1, 2027
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Bypass Complication
• Claudication, Intermittent
• Constriction, Pathologic
• Femoropopliteal Artery Occlusion
• Femoropopliteal Stenosis
• Intermittent Claudication
• Ischemia
• Peripheral Arterial Occlusive Disease

Intervention

Procedure:
• Balloon Angioplasty
Revascularisation procedures will be performed according to randomised list

Locations

Country	Name	City	State
Austria	University Hospital of Salzburg, Paracelsus Medical University	Salzburg

Sponsors (2)

Lead Sponsor	Collaborator
Paracelsus Medical University	MedAlliance Swiss Medical Technology

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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