Trial Parameters
Brief Summary
The primary objective of the clinical investigation is to assess the use of the Medtronic Valiant Thoracoabdominal Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device. Additionally, the study will assess technical success and treatment success at each follow-up interval.
Eligibility Criteria
Inclusion 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 acce