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BeFlared Versus VBX for FEVAR
Sponsor: Medical University of Vienna
Summary
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.
Official title: BeFlared FEVAR Stent Graft System© Versus GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis for Fenestrated Endovascular Aortic Repair - Randomized Controlled Unblinded Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
126
Start Date
2026-02-19
Completion Date
2033-02
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
Randomization
Preinterventional randomization of patients to one of two arms - fenestrated endovascular aortic repair with BeFlared FEVAR Stent Graft System© or GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.
Locations (1)
Medical University of Vienna, Department of General Surgery, Division of Vascular Surgery
Vienna, Vienna, Austria