Endovascular Repair With Fenestrated TREO Stent-Graft System in AAA (NCT07026877) | Clinical Trial Compass
RecruitingNot Applicable
Endovascular Repair With Fenestrated TREO Stent-Graft System in AAA
United States20 participantsStarted 2025-11-18
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. ≥20 mm length
✓. 20-32 mm diameter
✓. ≤60° angle relative to the axis of the suprarenal aorta
Exclusion criteria
What they're measuring
1
Proportion of patients with absence of a major adverse event (Primary Safety Endpoint)
Timeframe: 30-day post-procedure
2
Proportion of patients with successful aneurysm treatment through 12-months post-implant procedure (Primary Effectiveness Endpoint)
Timeframe: 12 months post-procedure
3
Successful delivery and deployment of the aortic stent-graft and all modular stent-graft components (Technical Success)