A Prospective, Multicenter, Non-Blinded, Non-Randomized Pivotal Study of the Fenestrated TREO Stent-Graft System in Subjects With Abdominal Aortic Aneurysms Requiring a Fenestrated Graft and Suitable for Endovascular Repair
The goal of this clinical trial is to learn if the Fenestrated TREO Stent-Graft System works to treat abdominal aneurysms in adults. An abdominal aneurysm is a bulge in the main blood vessel (the aorta) which carries blood from the heart, through the chest and abdomen. It will also learn about the safety of Fenestrated TREO Stent-Graft System. The main question it aims to answer is: Can the the Fenestrated TREO Stent-Graft System be used to treat participants with a specific type of abdominal aneurysm called a juxtarenal abdominal aortic aneurysm? Participants will: Have the the Fenestrated TREO Stent-Graft System implanted via an endovascular surgical procedure and visit the hospital for a follow up period of 5 years, for checkups, tests and imaging scans.
• 18 years or older at the time of consent
• Life expectancy is greater than 2 years
• An abdominal aortic or aorto-iliac aneurysm requiring a fenestrated graft and with morphology suitable for endovascular repair (confirmed by Computed Tomography (CT) with contrast performed within 6 months of planned implant procedure) as follows:
‣ Maximum aneurysm diameter of ≥5.5 cm for male ( ≥5.0 cm for female) or
⁃ Maximum AAA diameter exceeding two times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements (or saccular aneurysm that warrants treatment in the opinion of the investigator) or
⁃ Aneurysm with a history of growth \> 0.5 cm in 6 months and
⁃ Minimum 0 mm of healthy aorta\* below the most inferior renal artery that the physician plans on preserving and no renal artery involvement (juxtarenal aneurysms) or
⁃ At least one renal artery involved in the aneurysm and minimum 2 mm below the celiac (suprarenal aneurysms) \*Healthy aorta is defined as segment of aorta with parallel aortic wall with minimal (\<10%) or no difference in diameter and minimal atherosclerotic debris, thrombus, or calcification.
• Proximal landing zone:
‣ ≥20 mm length
⁃ 20-32 mm diameter
⁃ ≤60° angle relative to the axis of the suprarenal aorta
⁃ ≤60° angle relative to the long axis of the aneurysm
• Distal (iliac) landing zone with:
‣ 8-13 mm inside diameter/ ≥10 mm length
• Distal aortic diameter (above the iliac bifurcation) ≥70% of the sum of the iliac limb graft diameters
• Minimum 18 mm aortic lumen diameter at the level of the fenestrations
• Pathology that requires maximum 5 fenestrations in the main body
• Pathology that requires fenestration a minimum 3 mm apart (edge to edge)
• Branch vessels (to be bridged to the fenestrated graft) with:
‣ 5-9 mm diameters
⁃ ≥13 mm distal landing zone (or ≥15 mm if there is a gap between fenestration and target vessel)
• Adequate renal function to tolerate contrast-enhanced CTA
• Adequate vascular access compatible with required delivery systems
• Willingness to comply with the follow-up evaluation schedule documented in a signed informed consent prior to implant