The SIR-POBA Shunt Trial

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Arteriovenous Fistula Stenosis
• Intervention / Treatment: Radiation: Balloon Angioplasty

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • University Hospital of Salzburg, Paracelsus Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Paracelsus Medical University
• Collaborators: MedAlliance Swiss Medical Technology
• Investigators: Study Chair: Stephanie Rassam, MD, Resident Physician; Principal Investigator: Manuela Pilz, MD PD FEBVS, Senior Physician; Study Director: Klaus Linni, MD PD FEBVS, Head of Division of Vascular and Endovascular Surgery

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: September 20, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Constriction, Pathologic; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: 1037/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No