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

Starting soon · Not applicable

Conditions studied: Abdominal Aortic Aneurysms (AAA)

In brief

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.

Key facts

Study ID

NCT07754240

Run by

Lifetech Scientific (Shenzhen) Co., Ltd.

People needed

45

Starts

2026-09-30

Expected to finish

2033-05-30

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients with ruptured or leaking abdominal aortic aneurysm;
• Patients with infectious abdominal aortic aneurysm;
• Patients with abdominal aortic dissection;
• Patients with traumatic aortic disease;
• Patients with severe stenosis, calcification or mural thrombus in the stent anchoring zone likely to cause difficult covered stent apposition or the impact on stent patency;
• Patients with mesenteric blood flow mainly supplied by the inferior mesenteric artery;
• Patients with accessory renal artery original from abdominal artery;
• Patients who have undergone abdominal aortic surgery or endovascular intervention;
• Patients with stroke (Except for TIA), myocardial infarction or unstable angina within 3 months; The unstable angina is characterized by: progressively increased angina symptoms, new onset of angina while resting or during the night, or prolonged angina duration
• Patients with allergies to contrast agents, stent graft and delivery system materials (i.e., nitinol, polyester, PTFE, nylon polymer materials);
• Patients with allergies or contraindications to anticoagulant and antiplatelet drugs；
• Patients with abnormal hepatic and renal functions before operation (ALT or AST exceeding five times the upper limit of normal; STB exceeding two times the upper limit of normal; baseline serum creatinine exceeding 2.0 mg/dL (approximately 176.8 μmol/L));
• Patients who have undergone major surgery within 30 days prior to the procedure, or who are scheduled to undergo major surgery within 30 days following the procedure;
• Patients have morbid obesity (BMI of >40.0 kg/m2) or other clinical conditions that inhibit visualization of the aorta;
• Patients with systemic or localized infection likely to increase the risk of endovascular graft infection;
• Patients with connective tissue diseases related to the aorta, such as Marfan's syndrome;
• Patients with life expectancy of less than 1 year;
• Female patients who are in pregnancy or lactation, or plan to become pregnant;
• Patients who are not suitable for endovascular treatment according to the investigator's judgement;
• Patients who are participating in other device or drug clinical investigational studies.

Where it is running

• MBAL Heart and Brain EAD — Pleven, Bulgaria
• Military Medical Academy — Sofia, Bulgaria

Full record on ClinicalTrials.gov

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