Status:
WITHDRAWN
The SIR-POBA Bypass Trial
Lead Sponsor:
Paracelsus Medical University
Collaborating Sponsors:
MedAlliance Swiss Medical Technology
Conditions:
Peripheral Arterial Occlusive Disease
Bypass Complication
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 infrainguinal venous bypass stenosis. The main question we aim...
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
- Rutherford category 2 or 3 (in terms of lifestyle-limiting moderate or severe claudication symptomatology) or chronic critical ischemia (Rutherford 4-6)
- Venous bypass stenosis requiring intervention
- Confirmed inflow
- At least 1 crural outflow vessel
- Exclusion Criteria:
- Pregnant or lactating women
- Active infection or sepsis
- Patients currently participating in another clinical trial
- Unconfirmed inflow
- Intolerance to sirolimus
- Coagulopathy
- Radiotherapy
- Patients on immunosuppressive therapy
- Non-dialysis renal insufficiency (eGFR \< 45 ml/min/1.73m2)
- 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
NCT06056193
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