Clinical trial NCT06056206: The SIR-POBA Shunt Trial
Official title: SIRolimus-coated Versus Plain Old Balloon Angioplasty in Upper Extremity Arteriovenous Shunt Stenosis - the SIR-POBA Shunt Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Arteriovenous Fistula Stenosis
Lead sponsor: Paracelsus Medical University
Sponsor class: OTHER
Collaborators: name: MedAlliance Swiss Medical Technology
First posted: 2023-09-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Incidence of Primary Lesion Target Patency of the arteriovenous shunt stenosis
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: University Hospital of Salzburg, Paracelsus Medical University
Study officials:
affiliation: Resident Physician
name: Stephanie Rassam, MD
role: STUDY_CHAIR
affiliation: Senior Physician
name: Manuela Pilz, MD PD FEBVS
role: PRINCIPAL_INVESTIGATOR
affiliation: Head of Division of Vascular and Endovascular Surgery
name: Klaus Linni, MD PD FEBVS
role: STUDY_DIRECTOR
References: