The SIR-POBA Shunt Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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SIRolimus-coated Versus Plain Old Balloon Angioplasty in Upper Extremity Arteriovenous Shunt Stenosis - the SIR-POBA Shunt Trial

Conditions
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Arteriovenous Fistula Stenosis

Intervention / Treatment
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* Radiation: Balloon Angioplasty


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plain Balloon Angioplasty<br>Plain Balloon Angioplasty will be used to treat lesions. | Radiation: Balloon Angioplasty<br>* Revascularisation procedures will be performed according to randomised list.<br>* Other names: Endovascular Revascularization;|
| Active Comparator: Sirolimus-coated Balloon Angioplasty<br>Sirolimus-coated Balloon Angioplasty will be used to treat lesions after preparing vessel with plain balloon angioplasty. | Radiation: Balloon Angioplasty<br>* Revascularisation procedures will be performed according to randomised list.<br>* Other names: Endovascular Revascularization;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Primary Lesion Target Patency of the arteriovenous shunt stenosis | The incidence of patency will be analysed after reopening the stenosis of the arteriovenous shunt. | 2 years |