Pilot Study of the Endologix Fenestrated Stent Graft System

Inclusion criteria

• Informed consent understood and signed and pt agrees to all follow-up visits;
• Abdominal aortic aneurysm with diameter ≥5cm or ≥4cm which has increased by 0.5cm or more in the past six months
• Adequate iliac/femoral access compatible with the required delivery systems
• Non-aneurysmal infrarenal aortic neck <15mm in length
• Most caudal renal artery to aortoiliac bifurcation length at least 70mm
• Proximal non-aneurysmal aortic neck below the SMA with: diameter 18 to 34 mm; length at least 15 mm; angle (clock face) <60° to the aneurysm sac;
• Angle <60° (clock face) between the SMA and celiac artery
• Renal arteries both distal to the SMA by 0-35mm, within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clockface angle of 90° to 210° to each other
• Iliac anatomy suitable for commercial bifurcated stent graft;
• Minimum 3cm overlap achievable between fenestrated and bifurcated stent grafts

Exclusion criteria

• Life expectancy <1 year as judged by the investigator;
• Psychiatric or other condition that may interfere with the study;
• Participating in the enrollment or 30-day follow-up phase of another clinical study;
• Known allergy to any device component;
• Coagulopathy or uncontrolled bleeding disorder;
• Contraindication to contrast media or anticoagulants;
• Ruptured, leaking, dissecting, or mycotic aneurysm;
• Serum creatinine (S-Cr) level >2.0 mg/dL;
• Traumatic vascular injury;
• Active systemic or localized groin infection;
• Connective tissue disease (e.g., Marfan's Syndrome);
• Recent (within prior three months) cerebrovascular accident or myocardial infarction;
• Prior renal transplant;
• Length of either renal artery to be stented <13mm;
• Significant occlusive disease or calcification of either renal artery;
• An essential accessory renal artery;
• Indispensable inferior mesenteric artery;
• Untreated aneurysmal disease of the descending thoracic aorta;
• Clinically significant mural thrombus circumferentially in the suprarenal segment;
• Prior iliac artery stent implanted that may interfere with delivery system introduction;
• Unsuitable vascular anatomy
• Pregnancy (female patient of childbearing potential only)