First In Human Study for Small to Medium-sized Abdominal Aortic Aneurysm (AAA)

Inclusion Criteria:

• Male or Female aged 18 years or older

• Subject can understand the purpose of the trial, voluntarily participate in thetrial and sign the informed consent and is willing to complete the follow-upaccording to the requirements of the protocol.

• Infrarenal non-aneurysmal neck ≥15mm in length

• Aortic neck diameters ≤ 29mm

• Infrarenal neck angulation ≤ 60°

• Abdominal aneurysm from 3.5 cm to 5.0 cm.

• Overall AAA treatment length (distal renal to distal inferior margin of theaneurysm) not to exceed 10 cm

• Patient iliac or femoral arteries access vessels' size and morphology allowendovascular access of 14F introducer sheaths and catheters.

• Subject has > one-year life expectancy.

• Subject is American Society of Anesthesiology (ASA) grade 1 through 3, inclusive.

• Subject is able and willing to comply with 1, 3, 6, 12, 24 and 36-month follow-up.

Exclusion Criteria:

• Subject has an acutely ruptured or leaking or emergent aneurysm.

• Subject has a dissecting aneurysm.

• Subject has a mycotic or infected aneurysm.

• Subject has current vascular injury due to trauma.

• Subject's aneurysm is thoracic or suprarenal.

• Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.

• Subject has thrombus, calcification, and/or plaque that may compromise delivery.

• Subject has had a myocardial infarction within six (6) months prior to enrollment.

• Subject has current angina or other active cardiac condition such as congestiveheart failure, untreated or worsening atrial arrhythmia, ventricular arrhythmia, orvalvular disease.

• Subject has undergone other major surgery within the 30 days prior to enrollment.

• Subjects with any transient ischemic attack (TIA) or ischemic stroke within 3months.

• Known allergy to polyester or contrast material that cannot be pretreated.

• Subject is morbidly obese or has other clinical conditions that severely inhibitX-ray visualization of the aorta.

• Subject has connective tissue disease (e.g., Marfan syndrome, Eaton syndrome, orBessel's disease).

• Known contraindication to undergoing angiography or anticoagulation.

• Subject has active systemic infection.

• Subject is participating in another research study.

• Subject has other medical, social, or psychological problems that, in the opinion ofthe investigator, preclude them from receiving this treatment and the procedures andevaluations pre- and post-treatment.

• Women of childbearing potential who are pregnant, lactating, or planning to becomepregnant during the course of the trial.

• Subject has dialysis dependent renal failure or baseline serum creatinine level >2.0mg/dl.

• Subjects with liver dysfunction: alanine transaminase (ALT) or aspartatetransaminase (AST) is five times higher than the normal upper limit; serum totalbilirubin (STB) is two times higher than the normal upper limit.

• Subjects who are not suitable for endovascular treatment, as judged by theinvestigator.