First-In-Human Study Evaluating Aneurysm Sac Lining in AAA Patients

Inclusion criteria

• Patient can understand the purpose of the trial, voluntarily participate in the trial and sign the informed consent
• Patient is willing to complete the follow-up according to the requirements of the protocol.
• Patient AAA anatomy complies with "instructions for use" for commercial EVAR devices used
• ≥18 years old
• Abdominal aortic aneurysm with sac diameter ≥ 5.5cm in males and ≥ 5.0cm in females
• Maximum blood flow luminal diameter ≤ 50mm
• Eligible for endovascular aneurysm repair based on anatomical considerations, such as adequate iliac/femoral access
• Patient is American Society of Anesthesiology (ASA) grade 1 through 3, inclusive.

Exclusion criteria

• Concomitant Common Iliac Artery aneurysms ≥ 25mm
• Life expectancy <2 years
• Already participating in an investigational drug or device study
• Known allergy or contraindication to any study device material
• Coagulopathy or uncontrolled bleeding disorder
• Ruptured, leaking, inflammatory or mycotic aneurysm
• Connective tissue diseases (e.g., Marfan Syndrome)
• Unsuitable vascular anatomy that may interfere with device introduction or deployment, in the opinion of the investigator
• Aneurysmal or dissected disease of the descending thoracic aorta
• Previous surgical or EVAR repair for AAA
• Myocardial infarction and/or major heart surgery ≤ 90 days prior to the procedure
• Transient Ischemic Attack or stroke ≤ 90 days prior to the procedure
• Unstable angina or other active cardiac condition such as congestive heart failure, untreated or worsening atrial arrhythmia, ventricular arrhythmia or valvular disease ≤ 30 days prior to the procedure
• Unable or unwilling to comply with study follow-up requirements
• Serum creatinine level ≥ 180 µmol/L
• Patients of childbearing potential who are pregnant or planning to become pregnant during the course of the study
• Patient has other medical, social or psychological problems that, in the opinion of the investigator, study involvement would not be in their best interest.