| Eligibility |
Inclusion Criteria:
1. A patient may be entered into the study if the patient has at least one of the
following:
1. 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
2. aneurysm with a history of growth > 0.5 cm in 6 months
3. saccular aneurysm deemed at significant risk for rupture
4. symptomatic aneurysm greater than 4.5 cm
2. 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.
3. Proximal landing zone for the thoracic bifurcation stent graft that has:
1. = 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.
2. 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.
4. Minimum branch vessel diameter = 5 mm.
5. 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.
6. Patient is = 18 years of age.
7. Patient has a life expectancy > 1 year.
Exclusion Criteria:
1. Patient is a good candidate for and elects open surgical repair.
2. Patient can be treated in accordance with the instructions for use with a legally
marketed endovascular prosthesis.
3. Patient is eligible for enrollment in a manufacturer-sponsored IDE at the
investigational site.
4. Patient is unwilling to comply with the follow-up schedule.
5. Patient is unable or refuses to give informed consent.
6. Urgent or emergent presentation.
7. Patient is pregnant or breastfeeding.
8. Patient has a contained rupture.
9. Patient has a ruptured aneurysm.
10. Patient has a dissection in the treated portion of the aorta.
11. Obstructive stenting of any or all of the visceral vessels.
12. Poor performance status including 2 major system failures (cardiovascular, renal,
hepatobiliary, neuromuscular).
Medical Exclusion Criteria:
1. Patient has 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.
2. Patient has known hypersensitivity or contraindication to anticoagulation or contrast
media that cannot be adequately medically managed.
3. Patient has an uncorrectable coagulopathy.
4. Patient has a body habitus that would inhibit x-ray visualization of the aorta or
exceeds the safe capacity of the equipment.
5. Patient has had a major surgical or interventional procedure. unrelated to the
treatment of the aneurysm planned < 30 days of the endovascular repair.
6. Patient has unstable angina (defined as angina with a progressive increase in
symptoms, new onset at rest or nocturnal angina).
7. Patient has a systemic or local infection that may increase the risk of endovascular
graft infection.
8. Baseline creatinine greater than 2.0 mg/dL.
9. History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos
Syndrome).
Anatomical Exclusion Criteria:
1. Thrombus or excessive calcification within the neck of the aneurysm.
2. Anatomy that would not allow maintenance of at least one patent hypogastric artery.
3. Anatomy that would not allow primary or assisted patency of the left subclavian
artery.
Expanded Selection Criteria:
Subjects who fail to meet inclusion criteria for the primary study arm may be enrolled
under an expanded selection arm if they meet the following criteria.
Inclusion Criteria:
1. Patient that meets the criteria for inclusion in the primary study arm but has one or
more of the following criteria which would exclude them from the primary study arm:
1. Patient has a minimum branch vessel diameter less than 5 mm.
2. Patients presents urgently or emergently.
3. Patient has a contained rupture.
4. Patient has a ruptured aneurysm.
5. Patient has a type B dissection (subacute or chronic) in the portion of the aorta
intended to be treated.
6. Patient has poor performance status including two major system failures
(cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular).
7. Patient's baseline creatinine greater than 2.0 mg/dL.
8. Patient's anatomy that would not allow for maintenance of at least one
hypogastric artery.
9. Patient's anatomy that would not allow for primary or assisted patency of the
left subclavian artery.
Or
2. Patient that meets the criteria for inclusion in the primary study arm and:
1. Would not be eligible for the primary study arm per a documented reason other
than those outlined above, and
2. Per the opinion of the Principal Investigator, with concurrence of the IRB,
alternative therapies are unsatisfactory and the probable risk of using the
investigational device is no greater than the probable risk from the disease or
condition.
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