BeFlared Versus VBX for FEVAR
Recruiting now · Not applicable
Conditions studied: Fenestrated Endovascular Aortic Repair
In brief
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.
Key facts
- Study ID
- NCT07424885
- Run by
- Medical University of Vienna
- People needed
- 126
- Starts
- 2026-02-19
- Expected to finish
- 2033-02-01
- Last updated by the study team
- 2026-02-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- age < 18 years;
- all female patients with a pregnancy possibility (premenopausal)
Where it is running
- Medical University of Vienna, Department of General Surgery, Division of Vascular Surgery — Vienna, State of Vienna, Austria (enrolling)
Full record on ClinicalTrials.gov
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