First-in-Human Trial of the A3-Shield System for Stabilizing Abdominal Aortic Aneurysms

Inclusion Criteria: IC1. Male and female subjects ≥ 18 years at the time of screening. Female subjects must be of non-childbearing potential or otherwise not pregnant and not planning to become pregnant during the study follow-up period. IC2. Subject has a documented fusiform infrarenal abdominal aortic aneurysm characterized by the following: * Aneurysm size of 3.0-5.0 cm in maximum diameter for males; 3.0 - 4.5 for females (diameter measured in CTA perpendicular to the line of flow) * Aortic neck diameter ≥17mm and ≤ 29mm * Adequate landing zone for a tubular device of ≥ 30 mm length IC3. Access vessel size and morphology allows endovascular access of 14F (or larger) introducer sheaths and catheters IC4. Subject (or legal representative) understands the study requirements and the procedures and provided written informed consent. IC5. Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow-up visits. Exclusion Criteria: EC1. Subject has an aneurysm that is: * symptomatic * ruptured * thoracic * suprarenal * thoraco-abdominal * isolated ilio-femoral * mycotic * inflammatory * pseudoaneurysmatic * traumatic EC2. Subject has any type of aortic dissection. EC3. Subject has congenital connective tissue disease, e.g., Marfan's Syndrome or Ehlers-Danlos Syndrome. EC4. Subject has significant (\>25% of vessel circumference of aortic neck) aortic mural thrombus at the attachment site that could compromise fixation of the device. EC5. Subject has arterial access that is not acceptable for the device delivery systems as defined in the device Instructions For Use. EC6. Subject has had an acute myocardial infarction within 180 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin elevation). EC7. Subject has untreated coronary artery disease, which in the opinion of the treating physician, is clinically significant and requires revascularization. EC8. Subject has congestive heart failure (NYHA class III or IV) or high-grade valvular disease. EC9. Subject has had a cerebrovascular accident or transient ischemic attack within the past 90 days prior to study enrollment. EC10. Subject has end-stage renal disease or has a creatinine \> 2.0 mg/dl or is on dialysis. EC11. Subject has a history of bleeding diathesis or coagulopathy. EC12. Subject has Hgb \<9 g/dL, platelet count \<50,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<1,000 cells/mm3. EC13. Subject has had or plans to have an unrelated major surgical or interventional procedure (including trans-aortic interventions) within 30 days prior or post implantation of the device. EC14. Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated or has known hypersensitivity to the device components. EC15. Subject is participating in another investigational drug or device study and has not completed the follow-up required for that study at least 30 days prior to signing the informed consent form in this study. EC16. Subject is morbidly obese (body mass index ≥ 40 kg/m2) or has other documented conditions that inhibit radiographic visualization of the aorta. EC17. Subject has an active infection or chronic systemic illness at the time of the index procedure that may interfere with study objectives. EC18. Subject has current problems with substance abuse.Smoking is NOT an exclusion criterion. EC19. Subject has severe incapacitating dementia. EC20. Subject has a life expectancy of less than 24 months due to comorbid conditions based on the assessment of the investigator at the time of enrollment.