Evaluation of the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and Surgeon-Modified Endograft in Treating Aortic Pathologies

Inclusion Criteria:

• Juxtarenal, suprarenal and thoracoabdominal aortic pathology as follows inhemodynamically stable patients:

1. Intact or contained ruptured aortic or aortoiliac aneurysms (atherosclerotic/degenerative or saccular) involving or in close approximationto the visceral segment of the aorta.

2. Diameter >5.5 cm if asymptomatic, or 5.0 cm with enlargement of >0.5cm in 6 months.

3. History of growth >0.5 cm per year

4. Any size if ruptured or symptomatic

5. Penetrating aortic ulcer (PAU)

6. >2.0cm in depth

7. Any size if contained ruptured or symptomatic

General Exclusion Criteria:

• Less than 18 years of age

• Life expectancy less than 12 months based on the surgeon's assessment

• Pregnant or breastfeeding or planning on becoming pregnant within 60 months

• Inability or refusal to give informed consent

• Unwilling or unable to comply with the follow-up schedule

• Less than 30 days beyond primary endpoint for other investigative drug or devicestudy

Medical Exclusion Criteria:

• Known allergy to the device components (i.e. stainless steel, polyester, solder,gold, or nitinol)

• History of anaphylactic reaction to contrast material that cannot be adequatelypremedicated

• Systemic or local infection that may increase the risk of endovascular graftinfection.

• Baseline eGFR <30mL/min (calculated by the Modification of Diet in Renal Diseaseformula) and not on hemo- or peritoneal dialysis. If the patient is currently ondialysis, or is currently planning on initiating dialysis, then they may undergorepair.

• History of connective tissue disorders.

• Body habitus that would inhibit X-ray visualization of the aorta.

• Major surgical or interventional procedure unrelated to the treatment of theaneurysm planned ≤30 days of the endovascular repair.

• Unstable angina, defined as a progressive increase in symptoms, new onset at rest ornocturnal angina, or onset of prolonged angina.

• Irreversible coagulopathy

Anatomical Exclusion Criteria:

• Aortic transection due to acute trauma.

• Aortic dissection.

• Infectious ("mycotic") etiology of the aortic disease.

• Significant occlusive disease or tortuosity precluding delivery of the devicecomponents.

• Proximal Landing zone <20mm in length. The proximal landing zone can be within zones 2 through 8, with least 20mm of proximal seal and fixation in aorta or Dacron.

• Proximal neck, defined as the thoracic aorta distal to the native left carotidartery, measured outer wall to outer wall on a sectional image (CT) >41 mm indiameter or < 18 mm in diameter

• Distal landing zone <20mm in length if the landing zone is in the aorta, or <20mm ifthe landing zone is in the iliac arteries or in Dacron (in the event the patient hashad a previous or concomitant aortic or aorto-iliac reconstruction).

• Untreatable branch vessel stenosis.

• Anatomy that would not allow maintenance of at least one patent hypogastric artery.

• Signs that the inferior mesenteric artery is indispensable (i.e. angiographicvisualization or a large IMA, filling of SMA via collaterals, stenosis of celiac orSMA or oblique views) and the indispensible IMA is not amenable to treatment with agraft branch or fenestration.

• Branching, duplication, aneurysm or untreatable stenosis of the celiac, SMA or renalarteries that would preclude implantation of the investigational devices.