The Altura Abdominal Aortic Aneurysm (AAA) Endograft Safety and Feasibility Study

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 sealing
• •Subject has had a myocardial infarction within six (6) months prior to enrollment.
• •Subject has current angina or other active cardiac condition such as congestive heart failure, untreated or worsening atrial arrhythmia, ventricular arrhythmia, or valvular disease.
• •Subject has undergone other major surgery within the 30 days prior to enrollment.
• •Subject is pregnant or nursing.
• •Known allergy to nitinol or polyester or contrast material that cannot be pretreated.
• •Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.
• •Subject has connective tissue disease (e.g., Marfan's syndrome).
• •Subject has a bleeding disorder or anemia defined as hemoglobin \< 9.0 mg/dL.
• •Subject is hypercoagulable.
• •Subject is on dialysis or has compromised renal function as reflected by a serum creatinine \>2.2 mg/dL.
• •Subject has compromised hepatic function as measured by SGPT (ALT) \> three (3) times the upper limit of normal.
• •Subject has active systemic infection.
• •Subject is participating in another research study involving an investigational agent for the treatment of AAA.
• •Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment and the procedures and evaluations pre- and post-treatment.