Endograft Repair of Thoracoabdominal Aortic Aneury

Endograft Repair of Thoracoabdominal Aortic Aneury

Primary Investigator: Answini

Drug/Device Information
To assess the use of the Medtronic Valiant Thoracoabdominal Stent Graft System to repair thoracoabdominal aortic aneurysms
Prospective, single center, nonrandomized, multi-arm study
The Medtronic Valiant Thoracoabdominal Stent Graft System is made up of two main body components and makes use of several off-the-shelf FDA-approved stent graft components
The two custom main body grafts are the thoracic bifurcation and the visceral manifold
Geoffrey Answini, M.D., F.A.C.S.
Major Inclusion and Exclusion
An aneurysm meeting one of the following 4 criteria:
1. a maximum diameter of > 5.5 cm or 2 times the normal diameter just proximal to the aneurysm
2. a history of growth > 0.5 cm in 6 months
3. a saccular aneurysm deemed at significant risk for rupture
4. a symptomatic aneurysm greater than 4.5 cm
Patient has 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
Patient is ≥ 18 years of age
Patient can not be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
No urgent or emergent presentation
No ruptured aneurysm
No creatinine greater than 2.0 mg/dL
No history of connective tissue disorders (e.g., Marfan Syndrome, Ehler’s
Subjects who fail to meet inclusion criteria for the primary study arm may be enrolled under an expanded selection arm