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BeFlared Versus VBX for FEVAR

RecruitingNAAges 18 Years - anyAllMedical University of Vienna
NCT07424885 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This randomized controlled unblinded trial aimes to compare BeFlared FEVAR Stent Graft System (BeFlared) with GORE® VIABAHN® VBX Balloon Expandable Endoprothesis (VBX) in patients undergoing endovascular aneurysm repair with fenestrated device (FEVAR). Primary objectives: * compare cumulative device time between patients undergoing FEVAR with BeFlared and VBX brindging device; * compare target vessel (TV) instability at early, short-term and midterm follow-up in patients undergoing FEVAR with BeFlared and VBX brindging device. Secondary objectives: \- compare intraoperative TV technical success in patients undergoing FEVAR with BeFlared and VBX bridging device.

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📋 Eligibility rules (as published)
Inclusion Criteria: * written informed consent form signed by the patients before admission to the study; * age \> 18 years; * power of judgement and understanding capability of person; * patients with juxtarenal, pararenal, paravisceral AAA, EL Type IA with a previous history of EVAR procedure or TAAA (extent I-IV in accordance with Crawford Classification) undergoing emergency/elective treatment with FEVAR (custom-made or off-the-shelf endograft) at the Division of Vascular Surgery, Department of General Surgery, Medical University of Vienna. Exclusion Criteria: * age \< 18 years; * all female patients with a pregnancy possibility (premenopausal)
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What it tests

  • Randomization
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Where

1 site
Medical University of Vienna, Department of General Surgery, Division of Vascular Surgery
Vienna, Austria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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