A Clinical Investigational Study of Ankura™ II AAA, IE and AE Stent Graft System for Endovascular Treatment of Abdominal Aortic Aneurysm
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.
• Patients diagnosed with infrarenal abdominal aortic aneurysm and should meet at least one of the following conditions:
∙ 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.).
• Anatomical criteria:
‣ Diameter of the proximal abdominal aortic aneurysm neck ranges from 17 mm to 33 mm;
⁃ Length of the proximal abdominal aortic aneurysm neck ≥ 10 mm;
⁃ Angle of the proximal abdominal aortic aneurysm neck ≤ 75 degrees;
⁃ At least one side of the iliac artery anchorage zone has a diameter of 20 to 25 mm, while the other side of the iliac artery anchorage zone could be 7 to 25 mm；
⁃ Length of the bilateral iliac artery anchorage zone ≥ 15mm;
⁃ Adequate iliac or femoral vessel access
• Patients who are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent form, and are willing to complete the follow-up visits as per the protocol.