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.

- Aortic diameter at the most caudal renal artery of 18 to 36mm

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 (>70% stenosis);

- An essential accessory renal artery;

- Indispensable inferior mesenteric artery;

- 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)

- Existing renal stent;

- Pre-planned need for concomitant procedure (e.g. surgical conduit for vascular
access, hypogastric artery embolization/coil, renal artery angioplasty)