An interventional study of Balloon Angioplasty in Peripheral Arterial Occlusive Disease, Bypass Complication and Femoropopliteal Artery Occlusion, 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 Withdrawn at 1 site in Austria.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 infrainguinal venous bypass stenosis. The main question we aim to answer is, how patency is affected by each of the randomised treatment options.
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.
254 studies on the registry are indexed under Intermittent Claudication; 45 are open to participants now.
Browse Intermittent Claudication studies →Paracelsus Medical University is the lead sponsor of 33 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Plain Balloon Angioplasty will be used to treat lesions
Procedure: 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
Also known as: Endovascular Revascularization
Incidence of Primary Lesion Target Patency of the venous bypass stenosis
The incidence of patency will be analysed after reopening the stenosis of the venous bypass.
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This study is withdrawn, as verified in Sep 2023.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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Peripheral Arterial Occlusive Disease 1
Paracelsus Medical University