Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms

Inclusion Criteria

• •A patient may be entered into the study if the patient has at least one of the following
• •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
• •Aneurysm with a history of growth \> 0.5 cm in 6 months
• •Saccular aneurysm deemed at significant risk for rupture
• •Symptomatic aneurysm greater than or equal to 4.5 cm
• •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
• •Proximal landing zone for the thoracic bifurcation stent graft that has: (a) ≥ 2.5 cm of nonaneurysmal aortic segment including previously placed graft material (neck) distal to the left subclavian artery (LSA); (b) Diameter in the range of 26-42 mm; (c) 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
• •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
• •Life expectancy: \> 1 year
• •Branch vessel diameter \<5mm
• •Urgent or emergent presentation
• •Patient has a contained rupture
• •Patient has a ruptured aneurysm
• •Patient has a type B dissection (subacute or chronic) in the portion of the aorta intended to be treated
• •Poor performance status including two major system failures (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular)
• •Baseline creatinine greater than 2.0 mg/dL
• •Anatomy that does not allow maintenance of at least one hypogastric artery
• •Anatomy that does not allow primary or assisted patency of the left subclavian artery
• •Prior aneurysm repair that would involve relining of the previously placed graft material requiring placement of the investigational system in a landing zone that expands beyond any limits of the previously placed graft material
• •Obstructive stenting of any or all of the visceral vessels
• •Treatment of the patient population listed above will be considered for this expanded arm of the study if they are not a candidate for open surgical repair, cannot be treated with approved devices, and do not meet inclusion into the primary study arm as per opinion of the Principal Investigator, with the concurrence of the IRB.