Prospective Evaluation of Physician Modified Endografts for Aortic Disease
The purpose of this research is to assess safety and preliminary effectiveness of the Physician-Modified Terumo Treo Abdominal Stent-Graft System.
• An aneurysm with a maximum diameter of \>5.5cm in males and \>5.0cm in females in 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
• Extent of aorta to be treated: type II, III and IV thoracoabdominal.
• Subject is at high-risk of morbidity and mortality with open surgical repair as defined by FEV1 of \<1 liter or uncorrectable coronary disease, frailty, hostile abdomen.
• Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit.
• Non-aneurysmal aortic segment proximal to the aneurysm (neck) with a:
• Minimum neck length of 15mm
• Diameter in the range of 17-32
• Minimum branch vessel diameter greater than 5 mm
• Iliac artery distal fixation site
• An inside diameter of 8mm - 13mm and a length of ≥ 10mm or
• an inside diameter of \> 13mm - 20mm and a length of ≥ 15mm
• Age: ≥50 years old