Repair of Thoracoabdominal Aortic Aneurysms

Eligibility Criteria

• 1. A patient may be entered into the study if the patient has at least one of the following:
• 1. an aneurysm with a maximum diameter of \> 5.5 cm or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
• 2. aneurysm with a history of growth \> 0.5 cm in 6 months
• 3. saccular aneurysm deemed at significant risk for rupture
• 4. symptomatic aneurysm greater than 4.5 cm
• 2. Axillary or brachial and iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit.
• 3. Proximal landing zone for the thoracic bifurcation stent graft that has:
• 1. ≥ 2.5 cm of nonaneurysmal aortic segment including previously placed graft material (neck) distal to the left subclavian artery (LSA) diameter in the range of 26-42 mm.
• 2. adequate distance from the celiac artery, in order to accommodate cannulation from the antegrade access point when considering the total deployed length of the thoracic bifurcation and visceral manifold.
• 4. Minimum branch vessel diameter ≥ 5 mm.
• 5. Iliac artery or aortic distal fixation site, including both native tissue and previously placed graft, greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm.
• 6. Patient is ≥ 18 years of age.
• 7. Patient has a life expectancy \> 1 year.
• 1. Patient is a good candidate for and elects open surgical repair.
• 2. Patient can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis.
• 3. Patient is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site.
• 4. Patient is unwilling to comply with the follow-up schedule.
• 5. Patient is unable or refuses to give informed consent.
• 6. Urgent or emergent presentation.
• 7. Patient is pregnant or breastfeeding.
• 8. Patient has a contained rupture.
• 9. Patient has a ruptured aneurysm.
• 10. Patient has a dissection in the treated portion of the aorta.
• 11. Obstructive stenting of any or all of the visceral vessels.
• 12. Poor performance status including 2 major system failures (cardiovascular, renal, hepatobiliary, neuromuscular).