Clinical Study of the TriVascular Ovation™ Abdominal Stent Graft System

This is a Phase II prospective, consecutive enrolling, non-randomized multi-center clinical
evaluation of the safety and effectiveness of the Ovation Abdominal Stent Graft System when
used in the treatment of patients with AAA (Treatment Group) as compared to a performance
goal (Control Group).

150 study patients will be enrolled at up to 40 institutions. An additional 100 study
patients will be enrolled in the continued access phase.

Inclusion/Exclusion Criteria:

Inclusion Criteria

All patients must meet all of the following inclusion criteria to be eligible for
enrollment into this study:

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. 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 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.

13. Patient must be willing to comply with all required follow-up exams.

Exclusion Criteria

Patients that meet ANY of the following are not eligible for enrollment into the study:

1. Patient has a dissecting aneurysm

2. Patient has an acutely ruptured aneurysm

3. Patient has an acute vascular injury

4. Patient has a need for emergent surgery

5. Patient has a known thoracic aortic aneurysm or dissection.

6. Patient has a mycotic aneurysm or has an active systemic infection

7. Patient has unstable angina (defined as angina with a progressive increase in
symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)

8. Patient has had a myocardial infarction (MI) and/or stroke (CVA) within the past 6
months.

9. Patient has a major surgical or interventional procedure planned ≤30 days of the AAA
repair.

10. Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos
syndrome).

11. Patient has history of bleeding disorders or refuses blood transfusions.

12. Patient has dialysis dependent renal failure or baseline serum creatinine level >2.0
mg/dl

13. Patient has a known hypersensitivity or contraindication to anticoagulation or
contrast media that is not amenable to pre-treatment.

14. Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE),
PEG-based polymers, fluorinated ethylene propylene (FEP) or nitinol.

15. Patient has a body habitus that would inhibit X-ray visualization of the aorta

16. Patient has a limited life expectancy of less than 1 year

17. Patient is currently participating in another investigational device or drug clinical
trial

18. Patient has other medical, social or psychological conditions that, in the opinion of
the investigator, preclude them from receiving the pre-treatment, required treatment,
and post-treatment procedures and evaluations.