A Clinical Investigational Study of Ankura™ II AAA, IE and AE Stent Graft System for Endovascular Treatment of Abdominal Aortic Aneurysm
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- The incidence of Major adverse events (MAEs) within 30 days after operation.
Study Overview
Brief 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.
Detailed Description
The aorta is the largest artery in the human body, delivering oxygenated blood from the heart to the systemic circulation. An aortic aneurysm occurs when a weakened area of the aortic wall progressively dilates due to structural degeneration, resulting in an abnormal enlargement of the vessel. Abdominal aortic aneurysm (AAA) is characterized by localized dilatation of the abdominal aorta and represents one of the most common forms of aortic aneurysm.
An infrarenal abdominal aortic aneurysm (infrarenal AAA) is defined as an aneurysmal dilatation of the abdominal aorta located distal to the lowest renal artery and proximal to the aortic bifurcation. Infrarenal AAA is the most common anatomical subtype of AAA and represents the primary indication for endovascular aneurysm repair (EVAR) using standard infrarenal stent graft systems.
EVAR is a minimally invasive treatment approach that uses a covered stent graft to exclude the aneurysm sac from systemic blood flow, thereby reducing pressure on the aneurysm wall and minimizing the risk of aneurysm expansion and rupture. The procedure is typically performed through femoral arterial access. Under fluoroscopic guidance, the stent graft is delivered through the vascular system and deployed across the aneurysmal segment to establish a new blood flow channel while isolating the diseased aortic wall.
The Ankura™ II Abdominal Aortic Stent Graft System manufactured by Lifetech is the second generation of the Ankura™ stent graft system. This clinical investigation is conducted 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 (IE stent grafts with distal diameters of 24, 26, and 28 mm) for the endovascular treatment of abdominal aortic aneurysms.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Single Arm
Participants will undergo endovascular aneurysm repair (EVAR) using the Ankura™ II Abdominal Aortic Stent Graft System manufactured by Lifetech Scientific.
Intervention: Ankura™ II Abdominal Aortic Stent Graft System (Device)
Outcomes
Primary Outcomes
The incidence of Major adverse events (MAEs) within 30 days after operation.
Time Frame: within 30-day post 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
Time Frame: intraoperative and 12-month post operation
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.
Secondary Outcomes
- Incidence of the AAA enlargement >5 mm(pre-discharge, 6-month, 12-month and 2-5 years post operation)
- Incidence of endoleak(intraoperative, pre-discharge, 6-month, 12-month and 2-5 years post operation)
- Incidence of stent graft migration > 10mm(6-month, 12-month, 2-5 years post operation)
- Incidence of stent graft occlusion(intraoperative, pre-discharge,6-month, 12-month and 2-5 years post operation)
- Incidence of AAA rupture(intraoperative, pre-discharge, 6-month, 12-month, and 2- to 5-year post operation)
- Incidence of device-related adverse events (AEs)(30-day, 6-month, 12-month, and 2- to 5-year post operation)
- Immediate technical success rate(intraoperative)
- Incidence of perioperative delivery-related complications(intraoperative, pre-discharge, and 30-day post operation)
- All-cause mortality(6-month, 12-month, and 2- to 5-year post operation)
- AAA-related mortality(6-month, 12-month, and 2- to 5-year post operation)
- Incidence of serious adverse events (SAEs)(30-day, 6-month, 12-month, and 2- to 5-year post operation)
- Incidence of secondary intervention(pre-discharge, 30 days, 6-month, 12-month, and 2- to 5-year post operation)