BeFlared Versus VBX for FEVAR
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Vienna
About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
age < 18 years;
all female patients with a pregnancy possibility (premenopausal)
Trial design
Treatments tested in this trial
- Randomization
Treatment groups
126 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov