The Boston Scientific ENOVUS Trial

Inclusion Criteria: All patients must meet all of the following inclusion criteria to be eligible for enrollment into this study: Patient is > 18 years of age Females of childbearing potential have a negative pregnancy test at the time of treatment Patient has signed an Institutional Review Board (IRB) approved Informed Consent Form Patient is considered by the treating physician to be a candidate (i.e., categories I, II, or III) for elective open surgical repair of the AAA per American Society of Anesthesiology (ASA) refer to Appendix II. ASA grade IV patients may be enrolled provided their life expectancy is greater than 1 year. Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the following:•Abdominal aortic aneurysm >4.5 cm in diameter Aneurysm has increased in size by 0.5 cm in last 6 months. Maximum diameter of aneurysm exceeds one and one-half times the transverse dimension of an adjacent normal aortic segment Patient must be willing to comply with all required follow-up exams (open surgical control patients are followed through one year, Treatment Group patients are followed through five years in the study with lifelong follow up by physician thereafter). Exclusion Criteria: Patients that meet ANY of the following are not eligible for enrollment into the study: Aneurysm dissection Acutely ruptured aneurysm Acute vascular injury Need for emergent surgery Patient has a known thoracic aortic aneurysm or dissection. Patient has unstable angina (defined as angina characterized by progressive increase in anginal symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina) Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome). Patient has history of bleeding disorders or refuses blood transfusions. Patient has baseline serum creatinine level >2.0 mg/dl Patient has a known hypersensitivity or contraindication to anticoagulation that is not amenable to pre-treatment. Patient has a mycotic aneurysm or has an active systemic infection Patient is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta Patient has a limited life expectancy of less than 1 year Patient is currently participating in another investigational device or drug clinical trial Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving this treatment, pre-treatment, and post-treatment procedures and evaluations.