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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
The 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.
MBAL Heart and Brain EAD
Pleven, Bulgaria
RECRUITINGThe 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.
Time frame: within 30-day post operation
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.
Time frame: intraoperative and 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
Time frame: intraoperative, pre-discharge, and 30-day post operation
All-cause mortality
Time frame: 6-month, 12-month, and 2- to 5-year post operation
AAA-related mortality
Time frame: 6-month, 12-month, and 2- to 5-year post operation
Incidence of serious adverse events (SAEs)
Time frame: 30-day, 6-month, 12-month, and 2- to 5-year post operation
Incidence of device-related adverse events (AEs)
Time frame: 30-day, 6-month, 12-month, and 2- to 5-year post operation
Immediate technical success rate
Time frame: intraoperative
Incidence of the AAA enlargement >5 mm
Time frame: pre-discharge, 6-month, 12-month and 2-5 years post operation
Incidence of endoleak
Time frame: intraoperative, pre-discharge, 6-month, 12-month and 2-5 years post operation
Incidence of stent graft migration > 10mm
Time frame: 6-month, 12-month, 2-5 years post operation
Incidence of stent graft occlusion
Time frame: intraoperative, pre-discharge,6-month, 12-month and 2-5 years post operation
Incidence of secondary intervention
Time frame: pre-discharge, 30 days, 6-month, 12-month, and 2- to 5-year post operation
Incidence of AAA rupture
Time frame: intraoperative, pre-discharge, 6-month, 12-month, and 2- to 5-year post operation
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