BeFlared Versus VBX for FEVAR

BeFlared FEVAR Stent Graft System© Versus GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis for Fenestrated Endovascular Aortic Repair - Randomized Controlled Unblinded Clinical Trial

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.

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)