BeFlared FEVAR Stent Graft System© Versus GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis for Fenestrated Endovascular Aortic Repair - Randomized Controlled Unblinded Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Medical University of Vienna
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Cumulative device time
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
BeFlared group
Patients undergoing fenestrated endovascular aortic repair with BeFlared FEVAR Stent Graft System©
Intervention: Randomization (Other)
VBX group
Patients undergoing fenestrated aortic repair with GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Intervention: Randomization (Other)
Outcomes
Primary Outcomes
Cumulative device time
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- Intraoperative target vessel (TV) success(Intraoperative assessment during recruitment period of 2 years)
Investigators
Wolf Eilenberg
Ap. Prof. Priv. Doz. Dr., PhD, FEBVS
Medical University of Vienna