Fenestrated Endovascular Aortic Repair
Conditions
Keywords
FEVAR, endovascular aortic repair, bridging stent graft, cannulation, target vessel instability
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.
Interventions
OTHERRandomization
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.
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative target vessel (TV) success | Intraoperative assessment during recruitment period of 2 years | 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. |
Countries
Austria
Contacts
CONTACTWolf Hans Eilenberg, MD, PhD
CONTACTAnna Sotir, MD
Outcome results
None listed