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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Cumulative device time — Intraoperative assessment during recruitment period of 2 years 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.
Target vessel (TV) instability at follow-up — Early follow-up of first patients enrolled - end of midterm follow-up of last patients enrolled 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.
Trial sites (1)
Facility
City
Region
Status
Medical University of Vienna, Department of General Surgery, Division of Vascular Surgery
Vienna
State of Vienna
Recruiting
More Medical University of Vienna trials in Austria
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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