The SIR-POBA Shunt Trial

Not Applicable

Active, not recruiting

• Conditions: Arteriovenous Fistula Stenosis
• Interventions: Radiation: Balloon Angioplasty

• Registration Number: NCT06056206
• 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 arteriovenous shunt stenosis. The main question we aim to answer is, how patency is affected by each of the randomised treatment modality.

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 shunt 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.

The shunts are checked for functionality as part of the dialysis required three times a week and presented to our department beforehand in need. This saves chronically ill patients the additional waiting time in hospital outpatient departments.

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

• Age at least 18 years
• Informed consent with signature
• Maturated shunt, defined as already in use for two weeks
• Shunt stenosis in need of intervention

Exclusion Criteria

• Pregnant or breastfeeding women
• Active infection or sepsis
• Incapacitated patients
• Lesions in the affected stenosis already pretreated by stenting in the same area shunt.
• Patients currently participating in another study
• Central venous stenosis worthy of treatment
• intolerance to sirolimus
• coagulopathy
• radiotherapy
• patients on immunosuppressive therapy
• 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).

Exclusion Criteria

Not provided

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 arteriovenous shunt stenosis	2 years	The incidence of patency will be analysed after reopening the stenosis of the arteriovenous shunt.

Trial Locations

Locations (1)

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