EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study

Open to people ages 18 years and up

A patient who meets all of the following criteria potentially may be included in the study:

1. Male or female at least 18 years old;
2. Informed consent form understood and signed
3. Patient agrees to all follow-up visits;
4. Abdominal aortic aneurysm with sac diameter ≥5.0cm, or ≥4.5cm which has increased by ≥0.5cm within the last 6 months, or or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA <4 cm will be included.
5. Anatomically eligible for the Nellix System (per Instructions For Use):
   1. Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm);
   2. Aneurysm blood lumen diameter ≤60mm;
   3. Proximal non-aneurysmal aortic neck: length ≥10mm; diameter 18 to 28mm; angle ≤60° to the aneurysm sac;
   4. Most caudal renal artery to each hypogastric artery length ≥100mm;
   5. Common iliac artery lumen diameter between 9 and 35mm;
   6. Distal iliac artery seal zone with length of ≥10mm and diameter range of 9 to 25mm;
   7. Ability to preserve at least one hypogastric artery.
   8. Ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen diameter <1.40

A patient who meets none of the following criteria potentially may be included in the study:

1. Life expectancy <2 years as judged by the Investigator;
2. Psychiatric or other condition that may interfere with the study;
3. Participating in another clinical study;
4. Known allergy or contraindication to any device material;
5. Coagulopathy or uncontrolled bleeding disorder;
6. Ruptured, leaking or mycotic aneurysm;
7. Serum creatinine (S-Cr) level >2.0 mg/dL;
8. CVA or MI within three months of enrollment/treatment;
9. Aneurysmal disease of the descending thoracic aorta;
10. Clinically significant mural thrombus within the proximal landing zone (minimum 10mm) of the infrarenal non-aneurysmal neck (>5mm thickness over >50% circumference);
11. Connective tissue diseases (e.g., Marfan Syndrome);
12. Unsuitable vascular anatomy that may interfere with device introduction or deployment;
13. Pregnant (female of childbearing potential only).