Clincosm LogoSign in Get a demo

The SIR-POBA Bypass Trial

Sponsor
Paracelsus Medical University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06056193
Collaborator
MedAlliance Swiss Medical Technology (Other)
120
Enrollment
1
Location
2
Arms
48.4
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Balloon Angioplasty
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
SIRrolimus-coated Versus Plain Old Balloon Angioplasty (POBA) in Lower Extremity Autologous Venous Bypass Stenosis - The SIR-POBA Bypass Trial
Actual Study Start Date :
Sep 20, 2023
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Oct 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Plain Balloon Angioplasty

Plain Balloon Angioplasty will be used to treat lesions

Procedure: Balloon Angioplasty
Revascularisation procedures will be performed according to randomised list
Other Names:
  • Endovascular Revascularization

    		•
    Active Comparator: Sirolimus-coated Balloon Angioplasty

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

    Procedure: Balloon Angioplasty
    Revascularisation procedures will be performed according to randomised list
    Other Names:
  • Endovascular Revascularization

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Primary Lesion Target Patency of the venous bypass stenosis [2 years]

      The incidence of patency will be analysed after reopening the stenosis of the venous bypass.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital of Salzburg, Paracelsus Medical University Salzburg Austria 5020

    Sponsors and Collaborators

    • Paracelsus Medical University
    • MedAlliance Swiss Medical Technology

    Investigators

    • Principal Investigator: Manuela Pilz, MD PD FEBVS, Senior Physician
    • Study Director: Klaus Linni, MD PD FEBVS, Head of Division of Vascular and Endovascular Surgery
    • Study Chair: Stephanie Rassam, MD, Resident Physician

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Manuela Pilz, Senior Physician, Paracelsus Medical University
    ClinicalTrials.gov Identifier:
    NCT06056193
    Other Study ID Numbers:
    • 1036/2023
    First Posted:
    Sep 28, 2023
    Last Update Posted:
    Sep 28, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Manuela Pilz, Senior Physician, Paracelsus Medical University
    Autologous Vein Bypass
    Endovascular Revascularization
    Additional relevant MeSH terms:
    Intermittent Claudication
    Arterial Occlusive Diseases
    Constriction, Pathologic
    Ischemia

    Study Results

    No Results Posted as of Sep 28, 2023