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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Randomization
Other interventionPreinterventional 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.
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: BeFlared groupActive comparator 1 intervention
Group B: VBX groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative 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 years2
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 enrolledSecondary outcomes
1
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 yearsOther outcomes
1
Explorative objectives
Procedural metrics (operation time \[minutes\], dose of area product \[Gy cm2\], fluoroscopy time \[minutes\], dose of contrast agent applied \[mL\], intraoperative blood loss \[mL\]), duration of intensive care unit stay, TV patency, TV related endoleak formation, secondary TV related reinterventions as well as major adverse events (all-cause mortality, myocardial infarction, renal events, mesenteric events, respiratory events) at early, short-term and midterm postoperative outcome in patients undergoing FEVAR procedure with BeFlared or VBX bridging device will comprise explorative objectives (parameters) of this study.
Time frame
First patient enrolled - last patient completing midterm follow-upSponsors and contacts
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Source ClinicalTrials.gov