Status:
WITHDRAWN
The SIR-POBA Shunt Trial
Lead Sponsor:
Paracelsus Medical University
Collaborating Sponsors:
MedAlliance Swiss Medical Technology
Conditions:
Arteriovenous Fistula Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 answ...
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 opt...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
September 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06056206
Start Date
September 20 2023
End Date
October 1 2027
Last Update
June 29 2025
Active Locations (1)
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1
University Hospital of Salzburg, Paracelsus Medical University
Salzburg, Salzburg, Austria, 5020