The SIR-POBA Bypass Trial
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT06056193 |
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Recruitment Status :
Active, not recruiting
First Posted : September 28, 2023
Last Update Posted : September 28, 2023
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Sponsor:
Paracelsus Medical University
Collaborator:
MedAlliance Swiss Medical Technology
Information provided by (Responsible Party):
Manuela Pilz, Paracelsus Medical University
| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | September 20, 2023 | |||||||||
| First Posted Date ICMJE | September 28, 2023 | |||||||||
| Last Update Posted Date | September 28, 2023 | |||||||||
| Actual Study Start Date ICMJE | September 20, 2023 | |||||||||
| Estimated Primary Completion Date | October 1, 2025 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Incidence of Primary Lesion Target Patency of the venous bypass stenosis [ Time Frame: 2 years ] The incidence of patency will be analysed after reopening the stenosis of the venous bypass.
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | No Changes Posted | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | |||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | The SIR-POBA Bypass Trial | |||||||||
| Official Title ICMJE | SIRrolimus-coated Versus Plain Old Balloon Angioplasty (POBA) in Lower Extremity Autologous Venous Bypass Stenosis - The SIR-POBA Bypass Trial | |||||||||
| 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. | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Balloon Angioplasty
Revascularisation procedures will be performed according to randomised list
Other Name: Endovascular Revascularization
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Active, not recruiting | |||||||||
| Estimated Enrollment ICMJE |
120 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Estimated Study Completion Date ICMJE | October 1, 2027 | |||||||||
| Estimated Primary Completion Date | October 1, 2025 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Austria | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT06056193 | |||||||||
| Other Study ID Numbers ICMJE | 1036/2023 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Current Responsible Party | Manuela Pilz, Paracelsus Medical University | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor ICMJE | Paracelsus Medical University | |||||||||
| Original Study Sponsor ICMJE | Same as current | |||||||||
| Collaborators ICMJE | MedAlliance Swiss Medical Technology | |||||||||
| Investigators ICMJE |
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| PRS Account | Paracelsus Medical University | |||||||||
| Verification Date | September 2023 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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