LIFE Study: Least Invasive Fast-Track EVAR

The LIFE Study is a prospective, consecutively enrolling, non-randomized multi center
post-market registry to evaluate the ultra low profile (14F) Ovation Abdominal Stent Graft
Platform when using in the Percutaneous Endovascular Aneurysm Repair (P-EVAR) treatment of
patients with AAA using a Fast-Track EVAR protocol.

250 study patients will be enrolled at up to 40 institutions. Follow-up period is one month.

Inclusion Criteria:

- Patient is ≥ 18 years of age.

- 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).

- Patient has signed an IRB approved informed consent form.

- Patient is considered by the treating physician to be a candidate for elective open
surgical repair of the AAA.

- 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, or maximum diameter of aneurysm exceeds 1.5 times
the transverse dimension of an adjacent non-aneurysm exceeds 1.5 times the transverse
dimension of an adjacent non-aneurysmal aortic segment.

- Patient has suitable anatomy that allows use of the TriVascular Ovation® Abdominal
Stent Graft Platform.

- Patient has suitable femoral arteries at the percutaneous access site that allow use
of the Perclose ProGlide Suture-Mediated Closure System via the pre-close technique.

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

Exclusion Criteria:

- Patient has a need for emergent surgery.

- Patient has a dissecting aneurysm.

- Patient has an acutely ruptured aneurysm.

- Patient has an acute vascular injury.

- Patient has had a previous repair of the abdominal aortic aneurysm or the iliac
artery.

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

- Patient has unstable angina.

- Patient has unstable peripheral artery disease with critical limb ischemia.

- Patient has congestive heart failure.

- Patient has had a myocardial infarction and/or stroke within the past 3 months.

- Patient requires use of techniques that would cover the renal arteries.

- Patient requires planned adjunctive devices to complete the procedure.

- Patient has a major surgical or interventional procedure planned during or within ±30
days of the AAA repair.

- Patient has history of connective tissue disease.

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

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

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

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

- Patient is on home oxygen.

- Patient is morbidly obese (BMI ≥40 kg/m2).

- Patient was admitted from a skilled nursing facility.

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

- Patient has an inability to be discharged within 1 day of the procedure.

- Patient is currently participating in an investigational device or drug clinical
trial.

- 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.