ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES
Study Phase: N/A
Recruitment Status: Recruiting
Start Date: May 21, 2021
End Date: June 01, 2028
Inclusion Criteria:
- 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 has provided written informed consent CT Angiographic Inclusion Criteria
- Subject meets the other anatomical requirements according to the locally applicable Endurant II/IIs stent graft system, Heli-FX EndoAnchor system, Terumo Fenestrated Anaconda (available in EU only) and/or Cook Zenith Fenestrated Graft Instructions for Use
- Proximal neck length of the aorta within 4-15mm and a minimum circumferential sealing zone of 8mm
- Aortic neck diameter from 19 to 31mm
- Infrarenal neck angulation ≤45°
Exclusion Criteria:
- 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
- Subject with a MI or CVA within 3 months prior to index procedure
- Subject with known Connective Tissue Disease
- Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to post-treatment
- Subject who has undergone prior endovascular or open surgical treatment for abdominal aortic aneurysm
- Subject requires emergent aneurysm treatment, for example, trauma or rupture
- Subject has a known hypersensitivity or allergies to study device implant material
- Subject has an aneurysm that is:
- Suprarenal, pararenal, or thoracoabdominal
- Mycotic
- Inflammatory
- Pseudoaneurysm
- Subject is presenting with thrombus or calcification of the proximal aneurysm neck: circumferential >50%
- Pre-op stenosis of the renal arteries > 50%
- Subject has active infection or history of COVID-19. History of COVID-19 is defined as availability of positive COVID-19 test with sequelae or hospitalization for treatment of COVID-19.
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Conditions:
- Aneurysm
- Aortic Aneurysm
- Aortic Aneurysm, Abdominal