The SIR-POBA Shunt Trial

Arteriovenous Fistula Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06056206
• Other study ID #: 1037/2023
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 20, 2023
• Est. completion date: October 1, 2027

Study information

• Verified date: September 2023
• Source: Paracelsus Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: October 1, 2027
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Arteriovenous Fistula Stenosis
• Constriction, Pathologic
• Fistula

Intervention

Radiation:
• Balloon Angioplasty
Revascularisation procedures will be performed according to randomised list.

Locations

Country	Name	City	State
Austria	University Hospital of Salzburg, Paracelsus Medical University	Salzburg

Sponsors (2)

Lead Sponsor	Collaborator
Paracelsus Medical University	MedAlliance Swiss Medical Technology

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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