An interventional study of Balloon Angioplasty in Arteriovenous Fistula Stenosis, sponsored by Paracelsus Medical University. Withdrawn at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-29.
Sponsored by Paracelsus Medical University · Not applicable, Interventional, and Treatment
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.
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.
Paracelsus Medical University is the lead sponsor of 33 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Plain Balloon Angioplasty will be used to treat lesions.
Radiation: 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.
Also known as: Endovascular Revascularization
Incidence of Primary Lesion Target Patency of the arteriovenous shunt stenosis
The incidence of patency will be analysed after reopening the stenosis of the arteriovenous shunt.
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Paracelsus Medical University