Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms

This is a phase II, multi-center, non-blinded, non-randomized study of treatment with the
Treovance Stent-Graft in subjects with abdominal aortic aneurysms. The study will include 150
subjects treated with the Treovance Stent-Graft at a maximum of 30 investigational sites.
There will be no prospective control group. Subjects diagnosed with infrarenal abdominal
aortic aneurysms enrolled in the trial will be treated with the Treovance Stent-Graft with
Navitel Delivery System. Pre-procedure baseline data will be gathered, as well as
post-procedure assessments prior to hospital discharge and 30 days, 6 months, and 12 months
post-implantation. In addition, annual follow-up visits out to 5 years will be conducted.

The primary goal of this study is to gather safety and effectiveness data on the Treovance
device. A maximum of 150 endovascular subjects will be required to fulfill the U.S. Phase II
requirements. The data from this study will be submitted to the FDA and used to support
approval in the U.S.

There are two primary objectives, efficacy and safety of the Treovance Stent-Graft in
subjects with infrarenal aortic aneurysms:

- Primary Efficacy will be evaluated by successful aneurysm treatment 12 months
post-implant

- Primary Safety will be assessed by composite major adverse event (MAE) rate at 30-days

Secondary objectives involve assessment of major device-related events and major morbidity.

Inclusion Criteria:

- Subject must be diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or
without iliac artery involvement

- Subject must have an infrarenal AAA that is > 4.5 cm in diameter for males, or > 4.0
cm in diameter for females, or has increased in diameter by 0.5 cm in the last 6
months

Exclusion Criteria:

- Subject has a dissection in abdominal aorta, ruptured aneurysm, or symptomatic
aneurysm (as determined by treating physician)

- Subject has had a prior AAA repair (endovascular or surgical)

- Subject is participating in another research study, has received investigational study
drug within 30 days of planned procedure, or has received an investigational device
within one year of planned procedure