Clinical Trial

A Clinical Investigational Study of Ankura™ II AAA, IE and AE Stent Graft System for Endovascular Treatment of Abdominal Aortic Aneurysm

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Summary
The objective of this clinical investigational study is to evaluate the safety and efficacy of the Ankura™ II AAA, AE Stent Graft System and the large-size Ankura™ II IE Stent Graft System (i.e., IE stent grafts with distal diameters of 24, 26, and 28 mm) for endovascular treatment of abdominal aortic aneurysm in patients with infrarenal abdominal aortic aneurysm who are suitable for endovascular intervention. The primary safety endpoint is the incidence of major adverse events within 30 days after the procedure. The primary efficacy endpoint is the 12-month treatment success rate.
Protocol Amendment History 2 changes
notable Primary completion moved earlier: 2032-12-30 -> 2028-12-30 2026-08-13
minor Completion pushed: 2033-05-30 -> 2033-06-30 2026-08-13
Trial Details
NCT Number NCT07754240
Lead Sponsor Lifetech Scientific (Shenzhen) Co., Ltd.
Conditions Abdominal Aortic Aneurysms (AAA)
Enrollment 45 participants
Start Date 2026-09-30
Primary Completion 2028-12-30 (estimated)
Study Completion 2033-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-14