ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

Ki vehet részt

• 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°

Ki nem vehet részt

• Subject is participating in a concurrent study which may confound study results
• Subject with a MI or CVA within 3 months prior to index procedure
• Subject who has undergone prior endovascular or open surgical treatment for abdominal aortic aneurysm
• 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 has a known hypersensitivity or allergies to study device implant material
• 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
• Subject with eGFR <30 mL/min/m2 (KDOQI classification - exclude class IV and above) and or on dialysis
• Subject has a life expectancy <2 year
• Subject is female of childbearing potential in whom pregnancy cannot be excluded
• Subject requires emergent aneurysm treatment, for example, trauma or rupture
• 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%