The aim of this randomized study is to compare the safety and performance of EndoVascular Aneurysm Repair with ESAR using Endurant + Heli-FX™ EndoAnchor™ system and FEVAR using customizable grafts from Cook (Zenith Fenestrated Graft) and Terumo (Fenestrated Anaconda Graft) for the treatment of aortic aneurysms with short aortic neck (4 to 15mm).
Subject is >18 years old
Subject is scheduled for primary treatment of the abdominal aortic aneurysm with a non-aneurysmal infrarenal aortic sealing zone proximal to the aneurysm that is sufficiently healthy for a proximal neck length that is at least 4mm and not more than15 mm and has a circumferential minimum sealing zone length of 8 mm
Subject is not a candidate for safe, effective and durable standard EVAR due to challenging anatomical criteria as confirmed by the Core Lab screening
Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.
Subject is participating in a concurrent study which may confound study results
Subject has a life expectancy <2 year
Subject is female of childbearing potential in whom pregnancy cannot be excluded
Subject with eGFR <30 mL/min/m2 (KDOQI classification - exclude class IV and above) and or on dialysis
Parallel
ESAR treatment: Endograft + Heli-FX Endoanchor
DeviceESAR treatment: Endurant II or Endurant IIs endograft + Heli-FX Endoanchor
FEVAR treatment : Fenestrated endograft
DeviceCook Zenith Fenestrated Graft or the Terumo Fenestrated Anaconda Graft
Effectiveness Endpoint - Technical Success
Composite of technical success at index procedure, and freedom from type IA or type III endoleak, freedom from aneurysm related mortality (ARM), and freedom from secondary reinterventions through 12 months post index procedure.
Safety Endpoint - Freedom from Major Adverse Events
Freedom from MAE through 30 days post index procedure. MAE defined as: All-Cause-Mortality, Bowel Ischemia, Myocardial Infraction, Procedural Blood Loss \> 1000cc, Access related complications, permanent paraplegia and paraparesis at 30 days, disabling stroke, respiratory failure, or renal complications
Total contrast volume (ml) at index procedure
Total contrast volume (mL) at index procedure
Total fluoroscopy time (minutes) at index procedure
Total fluoroscopy time (minutes) at index procedure
Duration (minutes) of index procedure
3\. Duration (minutes) of index procedure (time between initial skin access to final closure of the last artery access site)
Adequate penetration of EndoAnchor implants as assessed by the Core Lab
Adequate penetration of EndoAnchor implants as assessed by the Core Lab
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FCRE (Foundation for Cardiovascular Research and Education)
Lead sponsor
Medtronic
Collaborator
