Post-Approval Study of the Ovation™/Ovation Prime™ Abdominal Stent Graft System

Inclusion Criteria

• •1. Patient is \> 18 years of age.
• •2. Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study).
• •3. Patient has signed an Institutional Review Board (IRB) approved Informed Consent Form.
• •4. Patient is considered by the treating physician to be a candidate for elective open surgical repair of the AAA (i.e., category I, II, or III per American Society of Anesthesiology (ASA) classification; refer to Appendix III: ASA Classification System). ASA category IV patients may be enrolled provided their life expectancy is greater than 1 year.
• •5. Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the following:
• •* Abdominal aortic aneurysm \>5.0 cm in diameter
• •* Aneurysm has increased in size by 0.5 cm in last 6 months.
• •* Maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment
• •6. Patient has patent iliac or femoral arteries that allow endovascular access with the TriVascular Ovation/Ovation Prime Abdominal Stent Graft System.
• •7. Patient has a suitable non-aneurysmal proximal aortic neck length of ≥ 7 mm inferior to the most distal renal artery ostium.
• •8. Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥10 mm. The resultant repair should preserve patency in at least one hypogastric artery.
• •9. Patient has a suitable non-aneurysmal proximal aortic neck luminal diameter between 16 and 30 mm.
• •10. Patient has suitable non-aneurysmal distal iliac luminal diameters between 8 and 20 mm.
• •11. Patient meets the following anatomic criteria: the distance from the most distal renal artery to most superior internal iliac artery measurement is at least 13 cm.
• •12. Patient has juxtarenal aortic neck angulation ≤ 60º if proximal neck is ≥10 mm and ≤ 45º if proximal neck is \<10 mm. Patient must be willing to comply with all required follow-up exams.
• •13. Patient must be willing to comply with all required follow-up exams.