NCT06056206

The SIR-POBA Shunt Trial

SIRolimus-coated Versus Plain Old Balloon Angioplasty in Upper Extremity Arteriovenous Shunt Stenosis - the SIR-POBA Shunt 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• Status: Withdrawn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 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.

Conditions

• Arteriovenous Fistula Stenosis

Interventions

Type	Name	Description
RADIATION	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