Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System

This study will evaluate the safety and effectiveness of the Nellix System among a wide
range of physicians and in consecutively enrolled subjects to assess outcomes
generalizability. Following appropriate government and ethics committee/IRB approval the
Nellix® EndoVascular Sealing System will be implanted into eligible patients who are
adequately informed and have consented to join the study. Enrolled patients will undergo a
high resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant
aortic and aortoiliac vasculature within three months of the scheduled procedure and at
specified follow-up intervals post-implantation. Follow-up visits will occur at 30 days, 6
months, and annually to 5 years to assess aneurysm morphology, the status of the implanted
devices, and relevant laboratory test results.

Inclusion Criteria:

- Male or female at least 18 years old;

- Informed consent understood and signed;

- Patient agrees to all follow-up visits;

- Have AAA with sac diameter ≥5.5cm, or ≥4.5 cm which has increased by >1.0cm in the
past year.

- Anatomic eligibility for the Nellix System per the instructions for use:

- Adequate iliac/femoral access compatible with the required delivery systems (diameter
≥6 mm);

- Aneurysm blood lumen diameter ≤60mm;

- Most caudal renal artery to aortoiliac bifurcation length ≥100mm;

- Proximal non-aneurysmal aortic neck: length ≥10mm; lumen diameter 16 to 32mm; angle
≤60° to the aneurysm sac;

- Common iliac artery lumen diameter between 8 and 35mm with blood lumen diameter
≤35mm;

- Ability to preserve at least one hypogastric artery.

Exclusion Criteria:

- Life expectancy <2 years;

- Psychiatric or other condition that may interfere with the study;

- Participating in enrollment of another clinical study

- Known allergy to device any device component;

- Coagulopathy or uncontrolled bleeding disorder;

- Ruptured, leaking or mycotic aneurysm;

- Serum creatinine level >2.0mg/dL;

- CVA or MI within three months of enrollment/treatment;

- Aneurysmal disease of the descending thoracic aorta;

- Clinically significant infrarenal mural thrombus (>5mm thickness over >50%
circumference);

- Connective tissue diseases (e.g., Marfan Syndrome)

- Unsuitable vascular anatomy;

- Pregnant (females of childbearing potential only).