• Presence of TAAA in:

‣ Men with TAAA greater than or equal to 6 cm in diameter

⁃ Women with TAAA greater than or equal to 5 cm in diameter

⁃ Men with TAAA larger than 5 cm in diameter and enlarging at a rate of more than 10mm/year

⁃ Women with TAAA larger than 4.5 cm in diameter and enlarging at a rate of more than 10mm/year or

⁃ Men or women with TAAA and an iliac artery aneurysm greater than or equal to 4 cm in diameter

• Life expectancy more than 2 years

• Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol

• Suitable arterial anatomy for endovascular TAAA repair with TAAA device:

‣ Proximal aortic landing zone:

• ≥ 20mm long

∙ ≤ 40mm and ≥ 20mm diameter in parallel aorta

∙ free from circumferential thrombus

∙ ≤ 60 degrees angulation

⁃ Mesenteric/renal aortic diameter ≥ 20mm

⁃ Mesenteric arteries:

• ≥ 10mm long segment of healthy artery for branch attachment

∙ Diameter ≥ 4mm and ≤ 12mm

∙ Absence of aberrant or early branching, aneurysm or dissection

⁃ Renal arteries:

• ≥ 10mm long segment of healthy artery for branch attachment

∙ Diameter ≥ 4mm and ≤ 8mm

∙ Absence of aberrant or early branching, aneurysm or dissection

⁃ Iliac artery access:

• ≥ 6mm diameter, and absence of severe calcification and tortuosity

∙ Or, planned creation of surgical conduit for TAAA device delivery

⁃ For patients with associated common iliac artery aneurysms (\>20mm diameter), adequate internal and external iliac artery landing zones and common iliac artery luminal diameter (for iliac branch device use):

• ≥ 10mm long segment of healthy internal iliac artery for branch attachment

∙ Internal iliac diameter ≥ 5mm and ≤ 12mm

∙ External iliac diameter ≥ 6mm diameter, and absence of severe calcification and tortuosity

∙ Minimum common iliac artery luminal diameter ≥ 14mm

∙ Or, in patients with bilateral common iliac artery aneurysms without suitable anatomy, planned surgical bypass to maintain patency of at least one internal iliac artery

• Patients deemed high risk for open repair (meeting one, or more, of the following criteria):

‣ Age ≥ 65 year

⁃ Cardiac disease:

• CAD (history of MI or angina with positive stress test and not revascularizable)

∙ LV Ejection fraction \< 40%

∙ Symptomatic CHF (NYHC Class II, III, or IV)

⁃ Pulmonary disease:

• Home oxygen therapy

∙ FEV1 \< 1.2 l/s

∙ Vital capacity \< 50% predicted

∙ PaCO2 \> 45 mm Hg or \< 60 mm Hg

⁃ Renal disease:

• ESRD on dialysis

∙ eGFR \< 60

⁃ Prior aortic surgery

⁃ Hostile abdomen

⁃ Portal hypertension (ascites or varices)

⁃ Coagulopathy

∙ AORTIC ARCH STUDY ARM

• Presence of aortic arch aneurysm in:

‣ Men with aortic arch aneurysm greater than or equal to 6 cm in diameter, or

⁃ Women with aortic arch aneurysm greater than or equal to 5 cm in diameter, or

⁃ Men with aortic arch aneurysm larger than 5 cm in diameter and enlarging at a rate of more than 10 mm/year, or

⁃ Women with aortic arch aneurysm larger than 4.5 cm in diameter and enlarging at a rate of more than 10 mm/year, or

⁃ Saccular aortic arch aneurysms deemed at significant risk for rupture based upon physician interpretation

• Life expectancy more than 2 years

• Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol.

• Suitable arterial anatomy for endovascular aortic arch repair with Aortic Arch Device:

‣ Aneurysm of the aortic arch beginning distal to the native coronary arteries or any patent coronary artery bypass

⁃ Proximal aortic landing zone:

• Native aorta or surgical graft

∙ ≥ 20 mm long

∙ ≤ 42 mm and ≥ 20 mm diameter in parallel aorta

∙ free from circumferential thrombus

⁃ Distal aortic landing zone:

• Native aorta or surgical graft

∙ ≥ 20 mm long

∙ ≤ 42 mm and ≥ 20 mm diameter in parallel aorta

∙ free from circumferential thrombus

∙ ≥ 50mm length from native coronary arteries or patent coronary bypass graft to innominate artery

⁃ Adequate supra-aortic trunk branch landing zone(s):

• Innominate artery (if applicable):

‣ Native vessel or surgical graft

⁃ Diameter: 8-22mm

⁃ Length of sealing zone ≥10mm

⁃ Acceptable tortuosity

⁃ Absence of dissection in landing zone

∙ Left (or right) common carotid artery (if applicable):

‣ Native vessel or surgical graft

⁃ Diameter 6-16mm

⁃ Length of sealing zone ≥10mm

⁃ Acceptable tortuosity

⁃ Absence of dissection in landing zone

∙ Left (or right) subclavian artery (if applicable):

‣ Native vessel or surgical graft

⁃ Diameter: 5-20mm

⁃ Length of sealing zone ≥10mm

⁃ Acceptable tortuosity

⁃ Absence of dissection in landing zone

⁃ Iliac artery access:

• ≥ 6mm diameter, and absence of severe calcification and tortuosity

∙ Or, planned creation of surgical conduit for TAAA device delivery

• Patients deemed high risk for open surgical aortic arch repair based upon consensus of both a qualified cardiac surgeon and a qualified vascular surgeon and meeting one, or more, of the following criteria):

‣ Age \> 70 years-old

⁃ Prior ascending or aortic arch repair

⁃ Multiple (≥2) median sternotomies

⁃ Ischemic cardiomyopathy with multi-level coronary artery disease and/or positive stress test

⁃ Chronic pulmonary disease with FEV1 \< 1500ml

⁃ Chronic kidney disease with eGFR ≤ 60 ml/kg/hr

⁃ Large aneurysm abutting the sternotomy

⁃ Severe deconditioning or immobility

⁃ Prior cervical irradiation

‣ Other medical condition associated with prohibitive high risk with open repair based upon multidisciplinary consensus (cardiac surgery and vascular surgery)

∙ APPLIES TO BOTH STUDY ARMS