Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms

The primary objective of the clinical investigation is to assess the use of the thoracic
bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients
having appropriate anatomy. The primary intent of the study is to assess safety (i.e. freedom
from major adverse events (MAE) at 30 days) and preliminary effectiveness (i.e., treatment
success and technical success) of the device (i.e., the proportion of treatment group
subjects that achieve and maintain treatment success at one year). Additionally, the study
will assess technical success and treatment success at each follow-up interval.

Inclusion Criteria:

- A patient may be entered into the study if the patient has at least one of the
following:

- An aneurysm with a maximum diameter of > 5.5 cm or 2 times the normal diameter just
proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline)
measurements

- Aneurysm with a history of growth > 0.5 cm in 6 months

- Saccular aneurysm deemed at significant risk for rupture

- Symptomatic aneurysm greater than 4.5 cm

- Axillary or brachial and iliac or femoral access vessel morphology that is compatible
with vascular access techniques, devices or accessories, with or without use of a
surgical conduit

- Proximal landing zone for the thoracic bifurcation stent graft that has:

- ≥ 2.5 cm of nonaneurysmal aortic segment including previously placed graft material
(neck) distal to the left subclavian artery (LSA) diameter in the range of 26-42 mm

- Adequate distance from the celiac artery, in order to accommodate cannulation from the
antegrade access point when considering the total deployed length of the thoracic
bifurcation and visceral manifold

- Minimum branch vessel diameter greater than or equal to 5 mm

- Iliac artery or aortic distal fixation site, including both native tissue and
previously placed graft, greater than or equal to 15 mm in length and diameter in the
range of 8 - 25 mm

- Life expectancy: > 1 year

Exclusion Criteria:

- Patient is a good candidate for and elects for open surgical repair

- Can be treated in accordance with the instructions for use with a legally marketed
endovascular prosthesis

- Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site

- Unwilling to comply with the follow-up schedule

- Inability or refusal to give informed consent

- Urgent or emergent presentation

- Patient is pregnant or breastfeeding

- Patient has a contained rupture

- Patient has a ruptured aneurysm

- Patient has a dissection in the portion of the aorta intended to be treated

- Obstructive stenting of any or all of the visceral vessels

- Poor performance status including two major system failures (cardiovascular,
pulmonary, renal, hepatobiliary, and neuromuscular)

Medical exclusion criteria

- Known sensitivities or allergies to the materials of construction of the devices,
including nitinol (Nickel: Titanium), polyester, platinum-iridium,
polytetrafluoroethylene (PTFE), platinum, gold, polyethylene, or stainless steel.

- Known hypersensitivity or contraindication to anticoagulation or contrast media that
cannot be adequately medically managed

- Uncorrectable coagulopathy

- Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe
capacity of the equipment

- Patient has had a major surgical or interventional procedure unrelated to the
treatment of the aneurysm planned < 30 days of the endovascular repair

- Unstable angina (defined as angina with a progressive increase in symptoms, new onset
at rest or nocturnal angina)

- Systemic or local infection that may increase the risk of endovascular graft infection

- Baseline creatinine greater than 2.0 mg/dL

- History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos
Syndrome)

Anatomical exclusion criteria

- Thrombus or excessive calcification within the neck of the aneurysm

- Anatomy that would not allow maintenance of at least one patent hypogastric artery

- Anatomy that would not allow primary or assisted patency of the left subclavian artery