Study of the Large Diameter GORE EXCLUDER® AAA Endoprosthesis in Abdominal Aneurysms

A Clinical Study Evaluating the Use of the GORE EXCLUDER® AAA Endoprosthesis - 31mm In the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms

The purpose of this study is to assess the safety and efficacy of the 31 mm GORE EXCLUDER® AAA Endoprosthesis in the treatment of infrarenal abdominal aortic aneurysms

The primary objective of this study was to estimate the safety of the 31 mm GORE EXCLUDER® AAA Endoprosthesis as compared to open surgical repair when used in the treatment of infrarenal abdominal aortic aneurysms. A secondary objective was to compare device performance of the original GORE EXCLUDER® AAA Endoprosthesis to the 31mm EXCLUDER when used in the treatment of infrarenal abdominal aortic aneurysms.

Inclusion Criteria:

• Infrarenal AAA > or equal to 4.5 cm in diameter
• Proximal infrarenal aortic neck length > or equal 15mm
• Anatomy meets 31mm EXCLUDER specification criteria
• Access vessel able to receive 20 Fr. introducer sheath
• Life expectancy >2 years
• Surgical candidate
• ASA Class I, II, III, or IV
• NYHA Class I, II, III
• 21 years of age or older
• Male or infertile female
• Ability to comply with protocol requirements including follow-up
• Signed Informed Consent Form

Exclusion Criteria:

• Mycotic or ruptured aneurysm
• Participating in another investigational device or drug study within 1 year
• Documented history of drug abuse within 6 months
• Coexisting thoracic aortic aneurysm (50% larger than proximal aorta)
• Myocardial infarction or cerebral vascular accident within 6 weeks
• Pulmonary insufficiency requiring chronic home oxygen therapy or inability to ambulate due to pulmonary function
• Renal insufficiency (Creatinine > 2.5 mg/dL) without dialysis
• Iliac anatomy that would require occlusion of both internal iliac arteries
• "Planned" occlusion or reimplantation of significant mesenteric or renal arteries
• "Planned" concomitant surgical procedure or previous major surgery within 30 days
• Previous prosthesis placement in the same position of the aorta or iliac arteries
• Degenerative connective tissue disease, e.g., Marfans and Ehlers Danlos Syndrome
• Proximal neck angulation > 60 degrees
• Presence of significant thrombus at arterial implantation sites