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.
18 years ≤ age ≤80years, no gender limitation.
The maximum diameter of abdominal aortic aneurysm is 55 mm or more in male patients or 50 mm or more in female patients;
The maximum diameter of abdominal aortic aneurysm has increased by more than 5 mm in the last 6 months or 10 mm in the last 1 year;
Abdominal aortic aneurysm oppresses important organs and viscera and causes symptoms (such as abdominal pain, lower back pain, etc.).
Patients with ruptured or leaking abdominal aortic aneurysm;
Patients with infectious abdominal aortic aneurysm;
Patients with abdominal aortic dissection;
Patients with traumatic aortic disease;
Single group
Ankura™ II Abdominal Aortic Stent Graft System
DeviceThe Ankura™ II Abdominal Aortic Stent Graft System consists of preloaded stent grafts and dedicated delivery systems. The system includes abdominal aortic aneurysm (AAA) stent grafts, iliac artery extension (IE) stent grafts, and aortic extension (AE) stent grafts, each with its corresponding delivery system.
The incidence of Major adverse events (MAEs) within 30 days after operation.
MAEs are defined as a composite of all-cause death, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, and intestinal ischemia.
12-month treatment success rate
The 12-month treatment success rate is a composite endpoint which should meet all of the following criteria: * immediate technical success * absence of aneurysm enlargement (growth \> 5 mm), stent graft migration (\> 10mm), aneurysm rupture, Type I / III endoleak and stent graft occlusion at 12-month post-operation * no secondary intervention through 12-month post-operation.
Incidence of perioperative delivery-related complications
including intraoperative delivery system-related conversion to open surgery, haemorrhage, hematoma and pseudoaneurysm in the delivery approach
All-cause mortality
AAA-related mortality
Incidence of serious adverse events (SAEs)
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