Safety, Efficacy, Longitudinal Costs and Patient-Centered Outcomes Using a TAAA Debranching Device

The primary objective of this clinical investigation is to assess the use of the TAAA
Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms. While surgery
remains a standard treatment for complex abdominal and thoracoabdominal aneurysms (TAAA), the
tolerance of some patients to recover from such extensive and invasive open aortic
reconstructions is poor. Endovascular repair may offer the opportunity to reduce patient risk
with less invasive approaches, improve quality of life, and serve to reduce the cost burden.
The primary technical safety endpoint is freedom from major adverse events (MAE) at 30 days
or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the
proportion of study subjects with treatment success at 1 year.

Inclusion Criteria:

Modified 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

Other inclusion criteria:

- 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 healthy/nondiseased tissue (including previously placed graft
material) (neck) distal to the left subclavian artery (LSA) diameter in the range
of 26-42 mm

- ≥2.5cm of surgical graft distal to the left subclavian artery (LSA) diameter in
the range of 26-42mm.

- 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 5 mm

- Iliac artery 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

- Patency of the four major visceral vessels (SMA, celiac, right renal, left renal)

- Age: ≥ 18 years old

- Life expectancy: > 1 year

Exclusion Criteria

General exclusion

- Patient is a good candidate for and elects 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 investigational device
exemption (IDE) at the investigational site

- Unwilling to comply with the follow-up schedule

- Inability or refusal to give informed consent by patient or legal representative

- Patient is pregnant or breastfeeding

- Patient has a contained rupture

- Patient has a ruptured aneurysm

- Patient has a dissection in the treated portion of the aorta

- Obstructive stenting of any or all of the visceral vessels

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

- Branch stenosis ≥ 70%

- 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