Clinical Study of Thoracic Aortic Aneurysm Exclusion

A vascular aneurysm is a permanent, localized dilatation of a blood vessel at least 1 1/2 to
2 times the normal vessel diameter. The aorta is the most frequent site for aneurysms, with
approximately 10% of aortic aneurysms located above the renal arteries in the thoracic
segment. Thoracic aortic aneurysms (TAAs) are less common than abdominal aorta, however,
detection of TAAs is increasing, perhaps due to an aging population, increased diagnostic
capability or an increase in prevalence.

Untreated thoracic aneurysms can be life-threatening. As many as 78% of untreated patients
with TAA die within 5 years after diagnosis, most often from rupture of the aneurysm.
Conventional surgical treatment, either tube graft placement or patch aortoplasty, is a high
risk surgical procedure. Repair of the thoracic descending aorta is performed with a
thoracotomy and cross-clamping of the aorta, with or without a shunt by-pass to maintain
distal perfusion.

As an alternative to conventional surgery, a less invasive endovascular procedure has been
developed that may be used to treat certain aneurysms. A collapsed stent-graft, a metal
stent coupled with a fabric graft, is introduced into the vasculature, advanced to the size
of the aneurysm, and deployed to span the aneurysm. The device creates a new aortic lumen,
excluding the aneurysm sac from blood flow while maintaining flow within the stent-graft.
This less invasive technique is designed to prevent or decrease the need for open surgery,
to reduce the need for blood transfusion, to decrease the use of anesthetics and other
drugs, and to speed recovery time. A reduction in intensive care and total hospital stay
should result, leading to an increase quality of life following the procedure and a
reduction in cost.

The primary objective of this investigational plan is to determine the safety of the Valiant
endoluminal device when used to exclude thoracic lesions: true descending thoracic aortic
aneurysms, dissections, penetrating ulcers, traumatic transections and traumatic and
degenerative pseudoaneurysms from blood flow in high risk and low risk patients who are
candidates for endoluminal repair.

Patients should be heparinized during the implant procedure (recommended activated clotting
time is 200-300 seconds). During implantation of the Valiant endoluminal stent-graft, the
pre-implant angiogram and CT scan are used together with (on-the-table) intravascular
ultrasound (IVUS), digital subtraction angiography (DAS), roadmapping, and angiography for
proper implant positioning. The Valiant endoluminal stent-graft endoprosthesis is inserted
by delivery catheter and introducer sheath via a surgical cutdown (e.g., external iliac
artery, femoral artery, common iliac artery conduit, etc.) approach. The introducer sheath
and delivery catheter containing the stent-graft is inserted over a guidewire and advanced
into the aorta and above the aneurysm. With the delivery catheter in the correct position,
the introducer sheath is then withdrawn further until the stent-graft is completely
deployed. A separate stent-graft balloon catheter system is provided with the device and may
be used along the full length of the implanted device to model the springs against the
vessel wall and to unravel possible wrinkles in the graft fabric. After deployment of the
stent-graft, angiography is performed to verify implant position and to check for the
presence of endoleaks.

Subjects will undergo an evaluation of the Valiant endoluminal stent-graft to determine the
safety and efficacy of the device as indicated by the adverse event rate, and to determine
the risk factors that are most predictive of a successful outcome when used to exclude
thoracic aortic aneurysms that require suprarenal fixation in high risk and low risk
patients. Follow-up will be completed at 1, 6, 12, 24, 36, 48, and 60 months. Subject
evaluation at 1 month will include a Complete Physical Exam, Labs (BUN and Creatinine), and
a Thoracic Spiral CT with and without IV contrast 2.5 mm. Subject evaluation at 6, 12, 24,
36, 48, and 60 months will include a Complete Physical Exam, Chest X-ray (AP, Lateral), Labs
(BUN and Creatinine), and a Thoracic Spiral CT with and without IV contrast 2.5 mm.

Inclusion Criteria:

- Subject is ≥ 18 years of age.

- Subject is not pregnant or lactating. Females of child-bearing potential must
practice a reliable method of contraception.

- Subject is diagnosed with one of the following conditions of the descending thoracic
aorta. All conditions must be verified by diagnostic imaging [ultrasonography,
computed tomography (CT), magnetic resonance imaging (MRI) or angiography].

- A true (i.e., atherosclerotic) supraceliac aneurysm (fusiform or saccular type)
with or without a co-existing aortic dissection or penetrating aortic ulcer;

- Aortic dissection of DeBakey Type I or II (Stanford A, proximal) in the absence
of an aneurysm; or

- Penetrating aortic ulcer in the absence of an aneurysm; or

- Traumatic transection; or

- Pseudoaneurysm - traumatic or degenerative (i.e., one that does not involve all
layers of the vessel and is not atherosclerotic in origin.

- Subject's anatomy is suitable for placement of the TALENT endoluminal stent-graft,
with a distinct proximal aneurysm neck of 10 mm or more in length and a distal
aneurysm neck of at least 10 mm.

- Subject has a TAA that is dilated to ≥ 5 cm in diameter, ≥ 1.5 times the diameter of
the adjacent native/non-aneurysmal aorta, or is symptomatic.

- Subject has a proximal and distal aortic neck diameter ≥ 18 mm and ≤ 42 mm.

- Subject has an arterial access site, either peripherally or via infrarenal abdominal
aorta that is adequate for introduction of the stent-graft delivery system.

- Subject has signed the informed consent.

- Subject will be available for the periodic follow-up (surveillance) after the
procedure.

- Aortic.

Exclusion Criteria:

- Subject has TAA with less than 10 mm proximal fixation length.

- Subject has an aneurysm that would require exclusion by the stent-graft of the
segment of the aorta that gives rise to dominant spinal cord/intercostal arteries.

- Subject has a lesion that prevents delivery or expansion of the device.

- Subject has systemic infection, or is suspected of having systemic infection.

- Subject has a known mycotic aneurysm.

- Subject is not available or is not willing to come back for periodic follow-up
(surveillance) after the procedure.