Back to resultsThe SIR-POBA Bypass Trial
Primary Purpose
Peripheral Arterial Occlusive Disease, Bypass Complication, Femoropopliteal Artery Occlusion
Status
Active
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Balloon Angioplasty
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Occlusive Disease focused on measuring Autologous Vein Bypass, Endovascular Revascularization
Eligibility Criteria
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).
Sites / Locations
- University Hospital of Salzburg, Paracelsus Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Plain Balloon Angioplasty
Sirolimus-coated Balloon Angioplasty
Arm Description
Plain Balloon Angioplasty will be used to treat lesions
Sirolimus-coated Balloon Angioplasty will be used to treat lesions after preparing vessel with plain balloon angioplasty
Outcomes
Primary Outcome Measures
Incidence of Primary Lesion Target Patency of the venous bypass stenosis
The incidence of patency will be analysed after reopening the stenosis of the venous bypass.
Secondary Outcome Measures
Full Information
NCT ID
NCT06056193
First Posted
September 20, 2023
Last Updated
September 20, 2023
Sponsor
Paracelsus Medical University
Collaborators
MedAlliance Swiss Medical Technology
1. Study Identification
Unique Protocol Identification Number
NCT06056193
Brief Title
The SIR-POBA Bypass Trial
Official Title
SIRrolimus-coated Versus Plain Old Balloon Angioplasty (POBA) in Lower Extremity Autologous Venous Bypass Stenosis - The SIR-POBA Bypass Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 20, 2023 (Actual)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
October 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Paracelsus Medical University
Collaborators
MedAlliance Swiss Medical Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 to answer is, how patency is affected by each of the randomised treatment options.
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 bypass 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Occlusive Disease, Bypass Complication, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis, Critical Limb-Threatening Ischemia, Claudication, Intermittent
Keywords
Autologous Vein Bypass, Endovascular Revascularization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Plain Balloon Angioplasty
Arm Type
Active Comparator
Arm Description
Plain Balloon Angioplasty will be used to treat lesions
Arm Title
Sirolimus-coated Balloon Angioplasty
Arm Type
Active Comparator
Arm Description
Sirolimus-coated Balloon Angioplasty will be used to treat lesions after preparing vessel with plain balloon angioplasty
Intervention Type
Procedure
Intervention Name(s)
Balloon Angioplasty
Other Intervention Name(s)
Endovascular Revascularization
Intervention Description
Revascularisation procedures will be performed according to randomised list
Primary Outcome Measure Information:
Title
Incidence of Primary Lesion Target Patency of the venous bypass stenosis
Description
The incidence of patency will be analysed after reopening the stenosis of the venous bypass.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuela Pilz, MD PD FEBVS
Organizational Affiliation
Senior Physician
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Klaus Linni, MD PD FEBVS
Organizational Affiliation
Head of Division of Vascular and Endovascular Surgery
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stephanie Rassam, MD
Organizational Affiliation
Resident Physician
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital of Salzburg, Paracelsus Medical University
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
The SIR-POBA Bypass Trial
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