The SIR-POBA Shunt Trial

Paracelsus Medical University (PMU)

Status

Withdrawn

Conditions

Arteriovenous Fistula Stenosis

Treatments

Radiation: Balloon Angioplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT06056206

1037/2023

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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).