Clinical Outcomes and Radiation Safety After Endovascular Repair of Complex AAAs Using Fenestrated- Branched Devices

This study is a prospective, single center, non-randomized, double-cohort study. For the
Fenestrated-CMD cohort a total of 150 patients will be enrolled. For the type I-III
thoracoabdominal cohort, a total of 100 patients will be enrolled. CMDs will be used
primarily. Off-the-shelf devices will be used in urgent cases and when the waiting period for
design and manufacturing of a CMD may not be considered acceptable. Staged endovascular
repair will be used for type I, II and III TAAAs, unless the condition of the patient
requires a single stage endovascular repair. A separate subgroup analysis of patients
undergoing procedures with off-the-shelf devices will be performed.

General Inclusion Criteria A patient is deemed suitable for inclusion in the study if the
patient has at least one the following:

1. Juxtarenal or suprarenal AAA and type I-IV thoracoabdominal aortic aneurysms with
diameter ≥5.0 cm in diameter or 2 times the normal aortic diameter;

2. Aneurysm with history of growth ≥0.5 cm/year;

3. Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic
diameter that is deemed to be at risk for rupture based upon physician interpretation.

4. Patients that are not eligible for treatment with commercially available endografts.

General Exclusion Criteria A patient must be excluded from the clinical investigation if
any of the following are true:

1. Age <18 years;

2. Life expectancy <2 years;

3. Pregnant, breast-feeding, or planning on becoming pregnant within 60 months;

4. Inability or refusal to give informed consent by the patient or a legally authorized
representative;

5. Unwilling or unable to comply with the follow-up schedule;

6. Prior surgical or interventional procedure within 30 days of the anticipated date of
the fenestrated procedure, with the exception of planned staged procedures to provide
access for repair (e.g. staged iliac conduit, thoracic endovascular aortic aneurysm
repair for proximal aneurysms), to facilitate the procedure by allowing open
reparation of a target artery not amenable to revascularization with the
investigational device, such us an internal iliac artery, subclavian artery or
visceral artery with early bifurcation, tortuosity or occlusive disease preventing
successful placement and alignment side stents, or to treat proximal aortic aneurysms.

7. Participation in another clinical or device trial, with the exception of observational
studies or participation in another investigational endovascular endograft protocol or
percutaneous aortic valve protocol, not encompassed by the IDE protocol (>30 days).

8. Patients with ruptured aortic aneurysm requiring urgent or emergent repair. Medical
Exclusion Criteria

Patients must be excluded from the study if any of the following conditions are true:

1. Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin,
silver), polypropylene, urethane or gold

2. History of anaphylactic reaction to contrast material that cannot be adequately
premedicated

3. Leaking or ruptured aneurysm associated with hypotension

4. Uncorrectable coagulopathy

5. Mycotic aneurysm or patients with evidence of active systemic infection.

6. History of connective tissue disorder (e.g. vascular Ehlers Danlos, Marfan's
syndrome), with the exception of those patients who had prior open surgical aortic
replacement or endovascular repair, where a surgical graft or an endograft would serve
as landing zone for the investigational endograft.

7. Body habitus that would inhibit x-ray visualization of the aorta and its branches.

Anatomical Exclusion Criteria

Patient must be excluded from the study if any of the following is true:

1. Inadequate femoral or iliac access compatible with the requirements of the required
delivery system.

2. Thoracic aortic aneurysms that extend into the arch, with the exception of those
patients who had prior open surgical aortic replacement or endovascular repair, where
a surgical graft or an endograft has been extended proximal and/or near the celiac
artery (functional type IV) that would serve as landing zone for the investigational
endograft.

3. Inability to perform a temporary or permanent open surgical or endovascular iliac
conduit for patients with inadequate femoral/iliac access.

4. Absence of a landing aortic segment in the distal thoracic aorta above the
diaphragmatic hiatus with:

1. A diameter measured outer to the outer wall greater than 38 mm or less than 19
mm;

2. Parallel aortic wall with >20% diameter change and with significant calcification
and/or thrombus in the selected area of the seal zone.

5. Visceral anatomy not compatible with the investigational device due to excessive
occlusive disease or small size not amenable to stent graft placement.

6. Unsuitable distal iliac arterial fixation site and anatomy:

1. Common iliac artery fixation site diameter, measured outer wall to outer wall on
a section image (CT)< 8.0 mm with inability to perform surgical conduit.

2. Iliac artery diameter, measured outer wall to outer wall on a sectional image
(CT) > 21 mm at distal fixation site, with inability to perform open internal
iliac artery revascularization or iliac branch stent graft or custom iliac
extension with fenestration.

3. Iliac artery distal fixation site <10 mm in length.

4. Inability to preserve at least one hypogastric artery. For patients in the type
I-III TAAA cohort, the intended use criteria are the same for both the
fenestrated/branched CMD vs the off-the-shelf device. The CMD will preferably be
used, unless an urgent repair is indicated or the waiting period for design or
manufacturing of the CMD is considered unacceptable.