Nectero EAST System Clinical Study

Inclusion Criteria:

1. Males and females ≥21 - ≤85 years of age. Females must be of non-childbearingpotential (menopause or sterilization).

2. Subject understands the purpose of the trial, agrees to voluntarily participate inthe trial, signs the informed consent and is willing to complete the follow-upaccording to the requirements of the protocol.

3. Infrarenal atherosclerotic fusiform abdominal aortic aneurysm from 3.5 cm to 5.0 cm (male) and 3.5 cm to 4.5 cm (female).

4. Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.

5. Overall AAA treatment length (distal renal to distal inferior margin of theaneurysm) not to exceed 130 mm.

6. Iliac and femoral artery access, vessel size and morphology allow endovascularaccess of 14F (or larger) introducer sheaths and catheters.

7. Subject meets American Society of Anesthesiology (ASA) grade 1 through 3 criteria,inclusive.

8. Subject has > three-year life expectancy.

9. Subject is able and willing to comply with all required follow-up clinic visitsincluding CT scans (pre-randomization, 6, 12, 18, 24 months and annually up to 5years).

Exclusion Criteria:

1. Subject has an acutely ruptured, leaking, dissecting or emergent aneurysm.

2. Subject has a symptomatic infrarenal abdominal aortic aneurysm.

3. Subject has a mycotic or infected aneurysm.

4. Subject has current vascular injury due to trauma.

5. Subject's aneurysm is thoracic, suprarenal or juxtarenal.

6. Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.

7. Subject has anatomy of diffuse, ulcerated, or extensive (shaggy) thrombus in theneck of the AAA, that in the opinion of the vascular surgeon/investigator, couldresult in embolization of the thrombus.

8. Subject has anatomy of calcification, and/or plaque within the ilio-femoral arteriesor severe infrarenal neck angulation that may compromise or does not allow deliveryof the Introducer Sheath or the delivery catheter of the Nectero EAST System.

9. Subject has had a myocardial infarction within six (6) months prior to enrollment orelevated CK enzymes or troponin prior to procedure.

10. Subject has current angina, unstable angina, or other active cardiac condition suchas congestive heart failure III and IV, atrial arrhythmia, ventricular arrhythmia,or valvular disease, requiring intervention.

11. Subject has undergone other major surgery within the 30 days prior to enrollment.

12. Subjects with any transient ischemic attack (TIA) or ischemic stroke within 3months.

13. Known allergy to contrast material, delivery system materials (i.e., nylon,polyurethane) and/or Pentagalloyl Glucose (PGG).

14. Subject is morbidly obese or has other clinical conditions that severely inhibitX-ray visualization of the aorta.

15. Subject has connective tissue/collagen disorder (e.g., Marfan syndrome, vascularEhlers-Danlos Syndrome, Loeys-Dietz Syndrome, Eaton Syndrome, Bessel-Hagen disease,etc.).

16. Known contraindication to undergoing angiography or receiving systemicanticoagulation.

17. Subject has active systemic infection.

18. Subject is participating in another research trial that could interfere with theresults of the trial (e.g., drug trial).

19. Subject has other medical, social, or psychological problems that, in the opinion ofthe investigator, preclude them from participation in the trial and to undergo theprocedures and evaluations pre- and post-treatment.

20. Subject has dialysis dependent renal failure or baseline serum creatinine level >2.5mg/dL or eGFR < 45 mL/min/1.73m2.

21. Subjects with liver dysfunction: alanine transaminase (ALT) or aspartatetransaminase (AST) which is 3 times higher than the normal upper limit; serum totalbilirubin (STB) that is 1.5 times higher than the normal upper limit or has clinicalevidence of jaundice.

22. Subjects that may not tolerate the lowering of their systolic blood pressure toapproximately 100mmHg, should not be considered for this study or treated using theNectero EAST System.

23. Subjects that may not be able to tolerate transient occlusion of the aorta shouldnot be considered for this study.

24. Subjects with saccular AAA.

25. Subjects with rapidly expanding AAA (previous diameter increases of ≥0.5 cm in 6-months or ≥1 cm in 1 year) as these should be evaluated for immediate repair.

26. Subjects who are not suitable for the Nectero EAST System treatment, as determinedby the investigator.