Safety and Effectiveness Trial of the Ventana Fenestrated Stent Graft System

Inclusion Criteria:

• Male or female at least 18 years old;
• Informed consent understood and signed and patient agrees to all follow-up visits;
• Have aortic aneurysm with maximum diameter ≥5.5cm, or between 4.5 and 5.5cm and rapidly expanding (>0.5cm in six months), or >50% larger than the normal aortic diameter

• Anatomically eligible for the Bifurcated System per the FDA-approved indications for use (IFU) and for the Fenestrated Stent Graft System:

  • 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 >=70mm
  • SMA to aortoiliac bifurcation length >=90mm;
  • Proximal non-aneurysmal aortic neck below the SMA with: diameter 18 to 34 mm; length >=15 mm; angle <=60° to the aneurysm sac;
  • Angle <=60° (clock face) between the SMA and CA
  • Renal arteries both distal to the SMA by <=35mm, within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clock face angle of 90° to 210° to each other .Common iliac artery distal fixation site with: distal fixation length >=15 mm; ability to preserve at least one hypogastric artery; diameter >=10 mm and <=23 mm; angle <=90° to the aortic bifurcation.

.The Endologix Fenestrated Proximal Extension Stent must have the ability to overlap the bifurcated stent graft by at least 3cm.

Exclusion Criteria:

• Life expectancy <2 years 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, or mycotic aneurysm;
• Aortic dissection
• 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 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)