Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2023-09-20
2027-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Plain Balloon Angioplasty
Plain Balloon Angioplasty will be used to treat lesions.
Balloon Angioplasty
Revascularisation procedures will be performed according to randomised list.
Sirolimus-coated Balloon Angioplasty
Sirolimus-coated Balloon Angioplasty will be used to treat lesions after preparing vessel with plain balloon angioplasty.
Balloon Angioplasty
Revascularisation procedures will be performed according to randomised list.
Interventions
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Balloon Angioplasty
Revascularisation procedures will be performed according to randomised list.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent with signature
* Maturated shunt, defined as already in use for two weeks
* Shunt stenosis in need of intervention
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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MedAlliance Swiss Medical Technology
UNKNOWN
Paracelsus Medical University
OTHER
Responsible Party
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Manuela Pilz
Senior physician
Principal Investigators
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Stephanie Rassam, MD
Role: STUDY_CHAIR
Resident Physician
Manuela Pilz, MD PD FEBVS
Role: PRINCIPAL_INVESTIGATOR
Senior Physician
Klaus Linni, MD PD FEBVS
Role: STUDY_DIRECTOR
Head of Division of Vascular and Endovascular Surgery
Locations
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University Hospital of Salzburg, Paracelsus Medical University
Salzburg, Salzburg, Austria
Countries
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Other Identifiers
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1037/2023
Identifier Type: -
Identifier Source: org_study_id
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