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The SIR-POBA Shunt Trial

Sponsor
Paracelsus Medical University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06056206
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 arteriovenous shunt stenosis. The main question we aim to answer is, how patency is affected by each of the randomised treatment modality.

Condition or Disease Intervention/Treatment Phase
  • Radiation: 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 shunt 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.

The shunts are checked for functionality as part of the dialysis required three times a week and presented to our department beforehand in need. This saves chronically ill patients the additional waiting time in hospital outpatient departments.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
SIRolimus-coated Versus Plain Old Balloon Angioplasty in Upper Extremity Arteriovenous Shunt Stenosis - the SIR-POBA Shunt 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.

Radiation: 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.

    Radiation: 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 arteriovenous shunt stenosis [2 years]

      The incidence of patency will be analysed after reopening the stenosis of the arteriovenous shunt.

    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

    • 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).

    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

    • Study Chair: Stephanie Rassam, MD, Resident Physician
    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Manuela Pilz, Senior physician, Paracelsus Medical University
    ClinicalTrials.gov Identifier:
    NCT06056206
    Other Study ID Numbers:
    • 1037/2023
    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
    Additional relevant MeSH terms:
    Arteriovenous Fistula
    Constriction, Pathologic
    Fistula

    Study Results

    No Results Posted as of Sep 28, 2023