Nectero EAST System Clinical Study

Eligibility Criteria

• 1. Males and females ≥21 - ≤85 years of age. Females must be of non-childbearing potential (menopause or sterilization).
• 2. Subject understands the purpose of the trial, agrees to voluntarily participate in the trial, signs the informed consent and is willing to complete the follow-up according 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 the aneurysm) not to exceed 130 mm.
• 6. Iliac and femoral artery access, vessel size and morphology allow endovascular access 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 visits including CT scans (pre-randomization, 6, 12, 18, 24 months and annually up to 5 years).
• 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 the neck of the AAA, that in the opinion of the vascular surgeon/investigator, could result in embolization of the thrombus.
• 8. Subject has anatomy of calcification, and/or plaque within the ilio-femoral arteries or severe infrarenal neck angulation that may compromise or does not allow delivery of 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 or elevated CK enzymes or troponin prior to procedure.
• 10. Subject has current angina, unstable angina, or other active cardiac condition such as 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 3 months.
• 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 inhibit X-ray visualization of the aorta.
• 15. Subject has connective tissue/collagen disorder (e.g., Marfan syndrome, vascular Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome, Eaton Syndrome, Bessel-Hagen disease, etc.).
• 16. Known contraindication to undergoing angiography or receiving systemic anticoagulation.
• 17. Subject has active systemic infection.
• 18. Subject is participating in another research trial that could interfere with the results of the trial (e.g., drug trial).
• 19. Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from participation in the trial and to undergo the procedures 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 aspartate transaminase (AST) which is 3 times higher than the normal upper limit; serum total bilirubin (STB) that is 1.5 times higher than the normal upper limit or has clinical evidence of jaundice.
• 22. Subjects that may not tolerate the lowering of their systolic blood pressure to approximately 100mmHg, should not be considered for this study or treated using the Nectero EAST System.
• 23. Subjects that may not be able to tolerate transient occlusion of the aorta should not 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 determined by the investigator.