Safety and Effectiveness Trial of the Ventana Fenestrated Stent Graft System

• Safety [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
  Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complicationl stroke; blood loss >1000cc
• Effectiveness [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
  Treatment Success=Procedural technical success and absence of aneurysm rupture, conversion to open repair, Type I endoleak after 30 days, Type III endoleak, clinically significant migration; aneurysm enlargement; or secondary intervention for resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defect

• Safety [ Time Frame: >30 Days to 5 Years ] [ Designated as safety issue: Yes ]
  Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complicationl stroke; blood loss >1000cc
• Distal Blood Flow [ Time Frame: Discharge to 5 Years ] [ Designated as safety issue: Yes ]
  Ankle-brachial index measurements
• Renal Dysfunction [ Time Frame: Discharge to 5 Years ] [ Designated as safety issue: Yes ]
  eGFR reduction >30% from baseline
• Device Performance [ Time Frame: 30 Days to 5 Years ] [ Designated as safety issue: Yes ]
  Aortic, fenestrated, and renal stent graft integrity and patency; migration; endoleak; and aneurysm sac morphology
• Clinical Utility Outcomes [ Time Frame: At the time of the procedure ] [ Designated as safety issue: Yes ]
  Clinical Utility Outcomes consists of: anesthesia time; fluoroscopy time; contrast volume; estimated blood loss; % requiring transfusion; procedure time
• Time in ICU [ Time Frame: In-Hospital ] [ Designated as safety issue: No ]
  Number of hours spent in the intensive care unit (ICU)
• Time to Hospital Discharge [ Time Frame: Hospital Discharge (Post-Procedure) ] [ Designated as safety issue: No ]
  Number of days from the index procedure to discharge from the hospital.

The purpose of this trial is to determine if the Ventana Fenestrated Stent Graft System is safe and effective for the endovascular repair of juxtarenal or pararenal aortic aneurysms.

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)