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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
126
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.
Medical University of Vienna, Department of General Surgery, Division of Vascular Surgery
Vienna, State of Vienna, Austria
RECRUITINGCumulative device time
Cumulative device time (measured in minutes) is defined as time between introduction of bridging stent graft (BSG) system into sheath and successful removal of deflated BSG flaring balloon for each of target vessels.
Time frame: Intraoperative assessment during recruitment period of 2 years
Target vessel (TV) instability at follow-up
TV instability at early, short-term and midterm follow up - defined as any death or aneurysm rupture event related to TV complication (e.g. TV endoleak or rupture) or any secondary intervention indicated to treat a TV related complication, including TV endoleak, disconnection, kinking, stenosis, occlusion, or rupture. Early follow-up is defined as radiological and clinical follow-up of the patients within the first 30 postoperative days or withing the hospital stay if longer than 30 days. Short-term follow-up encompass follow-up between 30 days and 6 months. Midterm follow-up refer to follow-up that occur within 6 months to 5 years after FEVAR procedure.
Time frame: Early follow-up of first patients enrolled - end of midterm follow-up of last patients enrolled
Intraoperative target vessel (TV) success
Intraoperative target vessel (TV) technical success is defined as successful TV catheterization and placement of bridging stent graft (BSG) with restoration and maintenance of flow in all intended TVs.
Time frame: Intraoperative assessment during recruitment period of 2 years
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