The SIR-POBA Shunt Trial

NCT06056206 | Withdrawn

• 1 other identifier: 1037/2023
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Arteriovenous Fistula Stenosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Plain Balloon Angioplasty

ACTIVE COMPARATOR

Plain Balloon Angioplasty will be used to treat lesions.

Radiation: Balloon Angioplasty

Sirolimus-coated Balloon Angioplasty

ACTIVE COMPARATOR

Sirolimus-coated Balloon Angioplasty will be used to treat lesions after preparing vessel with plain balloon angioplasty.

Radiation: Balloon Angioplasty

Interventions

Balloon Angioplasty RADIATION

Revascularisation procedures will be performed according to randomised list.

Also known as: Endovascular Revascularization

Plain Balloon Angioplasty; Sirolimus-coated Balloon Angioplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Paracelsus Medical University: lead
• MedAlliance Swiss Medical Technology: collaborator

Study Sites (1)

University Hospital of Salzburg, Paracelsus Medical University

Salzburg, Salzburg, 5020, Austria

Location

MeSH Terms

Interventions

Angioplasty, Balloon

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Stephanie Rassam, MD

  Resident Physician

  STUDY CHAIR

• Manuela Pilz, MD PD FEBVS

  Senior Physician

  PRINCIPAL INVESTIGATOR

• Klaus Linni, MD PD FEBVS

  Head of Division of Vascular and Endovascular Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 28, 2023
• Study Start: September 20, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 29, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)