Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System China Study(ATHENA)

• Heli-FX EndoAnchor System (Device): Subjects will be implanted with Heli-FX EndoAnchor System for AAA treatment

Primary outcomes

• Primary Effectiveness Endpoint [From procedure to 12 months after index procedure]: Composite treatment endpoint of Heli-FX within 12 months: * Technical success * No Type Ia endoleak * No endograft migration of proximal stent graft component * No aortic aneurysm rupture
• Primary Safety Endpoint [within 30 days post-operation]: Percentage of patients experiencing one or more major adverse events (MAE) within 30 days post-operation. MAEs are defined as any of the following: * All-cause mortality (ACM) * Heli-FX device-related serious adverse event (SAE) * Myocardial infarction (MI) * Stroke (excluding transient ischemic attacks) * Renal failure (excluding renal insufficiency) * Respiratory failure

Secondary outcomes

• Secondary Endpoints [From index-procedure to 3 years]: * Technical success and clinical success at the time of index procedure * All-cause mortality and aneurysm-related mortality at the time of index procedure, 30 days, 6 months, one year, and annually through 3 years. * Type Ia endoleak at 30 days, 6 months, one year, and annually through 3 years * Endograft migration at 6 months, one year, and annually through 3 years * Aneurysm sac change by diameter at 6 months, one year and annually through 3 years compared to the CT(Computed Tomography) imaging at 30 days after index procedure * Loss of endograft fabric integrity as a result of the EndoAnchor implant, rupture of the treated aneurys, conversion to open surgical repair at the time of index procedure, 30 days, 6 months, one year, and annually through 3 years * Myocardial infarction, stroke (excluding transient ischemic attacks), renal failure and respiratory failure at 30 days, 6 months, one year, and annually through 3 years

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Aged 18 years or older;
* Male or non-pregnant female patients; women of childbearing potential must undergo a pregnancy test prior to enrollment, and the result must be negative;
* Willing and able to provide written informed consent;
* Maximum diameter of the abdominal aortic aneurysm (AAA) ≥ 4.5 cm in females or ≥ 5 cm in males;
* Proximal neck diameter of the AAA ranging from 19 to 32 mm;
* Distal fixation zone length of both iliac arteries ≥ 15 mm;
* Diameter of iliac artery fixation zones on both sides ranging from 8 to 25 mm;
* ≤ 60° infrarenal and ≤ 45°suprarenal angulation OR ≤ 75°infrarenal and ≤ 60°suprarenal angulation with proximal necks ≥ 15 mm in length;
* Presence of high-risk anatomical criteria, defined as meeting any one of the following criteria:

  1. Proximal neck diameter > 28 mm and ≤ 32mm
  2. Proximal neck length ≥ 10 mm and < 15 mm
  3. Neck angulation ≥ 60°and ≤ 75° (angle between the long axis of the proximal neck and the long axis of the aneurysm sac)
  4. Conical neck (defined as diameter increased > 10% compared with the immediate infrarenal diameter over the first 10 mm beyond the lowest main renal artery)
  5. Investigator determined subject could benefit from this Heli-FX procedure
* Patients deemed by the investigator to be suitable candidates for elective AAA repair;
* Patients who agree to return to the treating investigator for all scheduled follow-up visits and are able to attend hospital-based follow-up;
* Life expectancy > 2 years

Exclusion Criteria:

* Myocardial infarction within the past 3 months;
* Systemic infection;
* Ruptured or leaking AAA;
* Infected or inflammatory AAA;
* Known hereditary connective tissue disorders (e.g., Marfan syndrome or Ehlers-Danlos syndrome);
* Concomitant thoracic aortic aneurysm or thoracoabdominal aortic aneurysm;
* Requirement for emergency AAA repair;
* History of prior AAA repair;
* Patient body habitus that interferes with required imaging studies;
* In the opinion of the investigator, the patient has serious comorbidities that may pose an unacceptable risk for general anesthesia or endovascular intervention;
* Planned major surgery (e.g., thoracic aorta, renal, superior mesenteric artery/celiac or lower extremity revascularization, IMA reimplantation, permanent vascular access, cholecystectomy) concurrent with or within 30 days before or after the AAA repair procedure;
* Renal failure requiring dialysis;
* Patient has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment;
* Known hypersensitivity or allergy to polyester, nickel, titanium, tantalum, chromium, molybdenum, and/or cobalt;
* Patients who cannot discontinue oral anticoagulation or antiplatelet therapy at the time of the study procedure;
* Bleeding diathesis or hypercoagulable state;
* Sealing zone thrombus, calcium or plaque > 2 mm in thickness or covering > 50% (180 degrees) of the vessel circumference;
* Irregularly shaped calcification and/or plaques at the proximal implantation sites that may interfere with proper deployment of the EndoAnchor implants;
* Mental disorders or other conditions that may impair the patient's ability to understand the nature, significance, and/or scope of the study;
* Participation in another investigational drug or device trial without having completed the required follow-up.
* Endograft planned to be used had not undergone in vitro evaluation to confirm its compatibility with the EndoAnchor implant and the aortic fixation system.