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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
ESAR treatment: Endurant II or Endurant IIs endograft + Heli-FX Endoanchor
Cook 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.
Time frame: through 12 months post-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
Time frame: through 30 days post-procedure
Total contrast volume (ml) at index procedure
Total contrast volume (mL) at index procedure
Time frame: at index procedure
Total fluoroscopy time (minutes) at index procedure
Total fluoroscopy time (minutes) at index procedure
Time frame: 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)
Time frame: at index procedure
Adequate penetration of EndoAnchor implants as assessed by the Core Lab
Adequate penetration of EndoAnchor implants as assessed by the Core Lab
Time frame: at index procedure
Clinical success
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RECRUITING...and 22 more locations
7\. Clinical success defined as technical success + freedom from intra-operative death and freedom from type IA/III endoleak in the first post-op image within 30 days.
Time frame: through 30 days post-procedure
Visceral artery patency or occlusion at 1, 12, 24 and 36 months follow-up
Visceral artery patency or occlusion at 1, 12, 24 and 36 months follow-up
Time frame: through 1,12,24 and 36-months post-op
Freedom from type Ia and III endoleaks at 1, 12, 24 and 36 months follow-up
Freedom from type Ia and III endoleaks at 1, 12, 24 and 36 months follow-up
Time frame: through 1,12,24 and 36-months post-op
Freedom from aneurysm related secondary reinterventions at 1, 12, 24 and 36 months follow-up
Freedom from aneurysm related secondary reinterventions at 1, 12, 24 and 36 months follow-up
Time frame: through 1,12,24 and 36-months post-op
Freedom from aneurysm related mortality at 1, 12, 24 and 36 months follow-up
Freedom from aneurysm related mortality at 1, 12, 24 and 36 months follow-up
Time frame: through 1,12,24 and 36-months post-op
Freedom from stent graft migration (>10mm change from 1-month follow-up imaging) at 12, 24 and 36 months follow-up
Freedom from stent graft migration (\>10mm change from 1-month follow-up imaging) at 12, 24 and 36 months follow-up
Time frame: through 12,24 and 36-months post-op
Sac dynamics (>5mm change from 1-month follow-up imaging): increase, stable, decrease at 12, 24, and 36 months follow-up
Sac dynamics (\>5mm change from 1-month follow-up imaging): increase, stable, decrease at 12, 24, and 36 months follow-up
Time frame: through 12,24 and 36-months post-op
Freedom from conversion to open repair at 1, 12, 24 and 36 months follow-up
Freedom from conversion to open repair at 1, 12, 24 and 36 months follow-up
Time frame: through 1,12,24 and 36-months post-op
Freedom from AAA rupture at 1, 12, 24 and 36 months follow-up
Freedom from AAA rupture at 1, 12, 24 and 36 months follow-up
Time frame: through 1,12,24 and 36-months post-op
Overall SCI rate, include transient events at 1 and 12 months follow-up
Overall SCI rate, include transient events at 1 and 12 months follow-up
Time frame: through 1 and 12 months post-op
Freedom from aortic neck-related secondary interventions
reinterventions for Type IAa endoleak, migration of the proximal stent graft, and progression of disease in the infrarenal aortic neck; progression of disease is defined as enlargement of the infrarenal aortic neck compared to the first postprocedural CT scan, as measured by either diameter, surface and/or volume.
Time frame: at 1-, 12-, 24- and 36-months follow-up