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 > 0.5 cmin 6 months.

3. History of growth > 0.5 cm per year

4. Any size if ruptured or symptomatic

5. Penetrating aortic ulcer (PAU)

6. > 2.0 cm in depth

7. Any size if contained ruptured or symptomatic

8. Subacute (>14 days) or chronic (>20 days) aortic dissection with aneurysmaldegeneration with at least one of the following:

9. Total aortic diameter > 5.5 cm if asymptomatic

10. Total aortic diameter > 4.5 cm if symptomatic

11. Total aortic diameter > 5.0 cm and history of growth > 0.5 cm in 6 months

• Aortic Arch pathology:

1. Aneurysm, Ascending thoracic aortic pseudoaneurysm, Type A thoracic aorticdissection, Retrograde type A thoracic aortic dissection between the Sinus ofValsalva and the innominate artery orifice (without involvement of the AorticValve), or Ascending penetrating aortic ulcer with and without intramuralhematoma

2. Suitable iliac artery and brachial artery access

3. Absence of severe landing zone (> 90 degree) angulation that would precludenecessary device delivery/seal/fixation.

4. Suitable iliac artery access to accommodate device delivery system.

5. Target arteries for arch branches:

6. < 24 mm diameter

7. Adequate landing zone length to obtain proximal and distal seal.

8. Free from dissection precluding adequate seal in distal landing zone ofbranch stent and severe tortuosity/thrombus/calcification.

• Aortic Arch Aneurysm

1. Proximal aortic fixation zone:

2. Native aorta or surgical graft

3. Diameter: 20 - 42 mm

4. Proximal neck length > 20 mm

5. Must occur distal to coronary arteries and any coronary artery bypass graftsthat are considered patent and necessary for proper cardiac perfusion.

6. Distal aortic fixation zone:

7. Native aorta or surgical graft

8. Diameter: 20 - 44 mm

9. Distal neck length > 20 mm. However, if dissection, distal graft may land indissected aorta.

10. Supra-aortic trunk (brachiocephalic) vessels (Any combination of arteries maybe used for repair) A. Innominate artery

11. Native vessel or surgical graft

12. Diameter: 8 - 22 mm

13. Length of sealing zone > 10 mm

14. Acceptable tortuosity B. Left (or right) common carotid artery

15. Native vessel or surgical graft

16. Diameter 5 - 20 mm

17. Length of sealing zone > 10 mm C. Left (or right) subclavian artery

18. Native vessel or surgical graft

19. Diameter 5 - 20 mm

20. Length of sealing zone > 10 mm

• Aortic Dissection

1. Access into the true lumen from the groin and at least one supra-aortic trunkvessel.

2. Seal zone in the target aorta (or surgical graft) that is proximal to theprimary dissection, such that a stent-graft would be anticipated to seal offthe dissection lumen.

3. Seal zone in the target supra-aortic trunk vessels that is distal to thedissection, anticipated to seal off the dissection lumen or surgically created.

4. True lumen size large enough to deploy the device and still gain access intothe target branch.

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 < 30 mL/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.

• 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.

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

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

• Juxtarenal, Suprarenal, and Thoracoabdominal:

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

• 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 < 20 mm in length if the landing zone is in the aorta, or < 20mm if the landing zone is in the iliac arteries or in Dacron (in the event thepatient has had 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 (IMA) is indispensable (i.e. angiographicvisualization or a large IMA, filling of superior mesenteric artery (SMA) viacollaterals, stenosis of celiac or SMA or oblique views) and the indispensable IMAis not amenable to treatment with a graft branch or fenestration.

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

• Aortic arch:

• Proximal neck > 44 mm or < 28 mm in diameter

• Inadequate landing zone to allow adequate distal seal of exclusion of false lumenperfusion in dissection.

• Untreatable branch vessel stenosis.

• Significant occlusive disease, tortuosity, or calcification that would preventendovascular access.

• Patients qualifying for an industry-sponsored study allowing for a similar repairwill be enrolled in the industry-sponsored study.