Endovascular Treatment of Thoracic Aortic Disease

This study is a prospective, non-randomized, single-site evaluation of the use of novel
endovascular technology to treat complex aortic disease.

In an effort to allow for the evaluation of patients with both complex anatomic condition and
challenging physiologic situations there are three study subsections as follows:

1. Ascending Arm Protocol: The intended use of the study is to provide endovascular therapy
to patients with ascending aortic pathology including aneurysm, pseudoaneurysm, and/or
aortic dissection who are considered high risk for conventional surgery. This will
involve disease in the aorta from the sinotubular junction to the innominate artery.

2. Aortic Arch Arm Protocol: The intended use of the study is to provide endovascular
therapy to patients with aortic arch pathology including aneurysm, pseudoaneurysm and/or
aortic dissection who are considered high risk for conventional surgery. This will
involve disease in aorta from the sinotubular junction to descending thoracic aorta.

3. Thoracobabdominal Aortic Arm Protocol: The intended use of the study is to provide
endovascular therapy to patients with thoracoabdominal aortic pathology including aortic
aneurysms, renal aneurysms, and superior mesenteric artery aneurysms. This will involve
the aorta from the left carotid artery origin through the iliac artery bifurcation.

In addition, the purpose of the study is also characterized based on the protocol arm that
patients are enrolled:

1. Ascending Arm Protocol: The purpose of this study is to assess the safety, efficacy, and
intermediate (or long-term) rupture free survival rate of high risk surgical patients
undergoing endovascular repair of ASCENDING AORTIC pathology including aortic
dissection, aortic aneurysm, and/or aortic pseudoaneurysm. The objectives of this arm
are as follows:

- To assess the safety, efficacy and intermediate (or long-term) durability of an
endovascular prosthesis as a means of preventing ascending aortic growth and
rupture in high risk patients.

- To measure the physiologic effects and outcomes of endovascular aneurysm repair.

- Establish selection criteria, improve device design, operative technique and
follow-up procedures for patients undergoing endovascular aneurysm repair.

2. Arch Arm Protocol: The purpose of this study is to assess the safety, efficacy, and
intermediate (or long-term) rupture free survival rate of high risk surgical patients
undergoing endovascular repair of AORTIC ARCH pathology including aortic aneurysm,
pseudoaneurysm and/or dissection. The objectives of this arm are as follows:

- To assess the safety, efficacy and intermediate (or long-term) durability of an
endovascular prosthesis as a means of preventing aortic arch growth and rupture in
high risk patients.

- To measure the physiologic effects and outcomes of endovascular aneurysm repair.

- Establish selection criteria, improve device design, operative technique and
follow-up procedures for patients undergoing endovascular aneurysm repair.

3. Thoracoabdominal Arm Protocol: The purpose of this study is to assess the long-term
safety, durability and rupture free survival of surgical patients undergoing
endovascular repair of the THORACOABDOMINAL AORTA involving pathologies that include
thoracoabdominal aortic aneurysms, renal artery aneurysms and superior mesenteric artery
aneurysms.

- To assess the long-term safety and durability of an endovascular prosthesis as a
means of preventing aneurysm growth and rupture in patients having aneurysms
involving the THORACOABDOMINAL AORTA.

- To measure the physiologic effects and outcomes of endovascular aneurysm repair.

- Establish selection criteria, improve device design, operative technique and
follow-up procedures for patients undergoing endovascular aneurysm repair involving
the THORACOABDOMINAL AORTA.

Ascending Arm Protocol:

1. General Inclusion Criteria (Must meet ALL of the following):

- Life expectancy greater than 2 years

- Suitable arterial anatomy

- Absence of systemic disease or allergy that precludes an endovascular repair

- Capable of giving informed consent and willingness to comply with follow up
schedule

- Patient is considered high or prohibitive risk for open surgical repair of the
ascending aneurysm or dissection

2. Anatomic Inclusion Criteria

- Have ONE of the following

1. Focal aneurysm in ascending aorta

2. Pseudoaneurysms and/or dissections that are distal to the sinotubular
junction.

3. The aneurysm should be >5.0 cm in diameter

4. Have morphology or growth suggestive of immanent rupture

- Must meet ALL of the following:

1. Proximal Fixation:

1. >15 mm aortic length distal to a patent coronary artery or coronary
artery bypass that are considered patent and necessary for proper
cardiac perfusion.

- Proximal fixation may occur in either native aorta or surgical
graft

- In the setting of the aortic dissection, the proximal fixation
must be proximal to the entry tear.

- In the setting of aortic dissection, true lumen size must be large
enough to allow deployment of the device

2. Aortic diameter at the sinotubular junction >20 mm and ≤ 38mm

2. Distal Fixation: a length of distal ascending aorta >5mm proximal to the
innominate artery whereby seal and fixation can be achieved (the dissection
flap may transcend the arch, but the seal must be achievable within the true
lumen of the dissection)

1. Aortic diameter (true lumen diameter in the setting of a dissection) at
the innominate artery is ≤ 42mm. If the diameter at the innominate
artery is ≥ 38mm the Low Profile version must be used

2. Distance from the ascending aorta to the innominate artery must be
>35mm

- Iliac artery access

1. Iliac anatomy must allow for the delivery of the endograft device which is
loaded within an 18F-24F sheath.

2. Conduits to the iliac vessels or aorta may be used if deemed necessary

3. In the setting of an aortic dissection, access into the true lumen
throughout the length of the aorta must be obtainable

Arch Arm Protocol

1. General Inclusion Criteria (Must meet ALL of the following):

- Life expectancy greater than 2 years

- Suitable arterial anatomy

- Absence of systemic disease or allergy that precludes an endovascular repair

- Capable of giving informed consent and willingness to comply with follow up
schedule

- Patient is considered high or prohibitive risk for open surgical repair of the
ascending aneurysm or dissection

2. Anatomic Inclusion Criteria

- Must meet ALL of the following:

1. Aneurysm of the ascending aorta or aortic arch/proximal descending thoracic
aorta that is >5.5cm or is considered to be at high risk for rupture or
dissection given the morphologic characteristics of the aneurysm (or
diverticulum).

2. Proximal aortic fixation zone:

1. Native aorta or surgical graft (If surgical graft in ascending aorta,
the angulation within the graft must be <90 degrees)

2. Diameter: 20-42mm

3. Proximal neck length ≥10mm

4. Ascending aortic length >50mm

5. Must occur distal to coronary arteries and any coronary artery bypass
grafts that are considered patent and necessary for proper cardiac
perfusion

3. Distal aortic fixation zone:

1. Native aorta or surgical graft

2. Diameter: 20-42mm

3. Distal neck length ≥10mm

4. Supra-aortic trunk (brachiocephalic) vessels

1. Although the prosthesis will typically have two branches, modifications
to the design will allow for a single branch or three branches. Thus,
it is generally planned that at least one extra-anatomic bypass graft
will be done in conjunction (or in a staged fashion) with the
procedure. The two vessels incorporated into the endograft repair would
most commonly be the innominate artery and left carotid artery.
However, the innominate artery may be coupled with the left subclavian
artery in the setting of a bovine arch whereby the flow to the left
carotid would come from a left subclavian to carotid bypass. Similarly,
the left carotid and subclavian artery may be branched, or simply one
vessel branched should specific anatomic limitations exist. In such a
situation, multiple extra-anatomic bypasses may be necessary. Thus the
inclusion criteria are defined for each artery, yet any combination of
arteries may be used for a repair.

2. Diameter of vessel(s) to be incorporated into endograft

- Innominate artery: 8-22 mm.

- Left (or right) common carotid artery: 6-16mm

- Left (or right) subclavian artery: 5-20mm

- Length of sealing zone ≥ 10mm

- Acceptable tortuosity

5. In the setting of an aortic dissection the following criteria must exist:

1. Access into the true lumen from the groin and at least one supra-aortic
trunk vessel

2. A sealing zone in the target aorta (or surgical graft) that is proximal
to the primary dissection, such that a stent graft would be anticipated
to seal off the dissection lumen

3. A sealing zone in the target supra-aortic trunk vessels that is distal
to the dissection, anticipated to seal off the dissection lumen, or
surgically created

4. A true lumen size large enough to deploy the device and still gain
access into the target branches

6. In the setting of a more distal disease, the repair may be coupled with a
thoracoabdominal branched device, infrarenal device, and/or internal iliac
branch device - typically performed in a staged fashion

7. Iliac anatomy must allow for the delivery of the arch branch device which is
loaded within an 18F-24F sheath. Conduits to the iliac vessels or aorta may
be used if deemed necessary.

Thoracoabdominal Arm Protocol

1. General Inclusion Criteria (Must meet ALL of the following):

- Life expectancy greater than 2 years

- Suitable arterial anatomy

- Absence of systemic disease or allergy that precludes an endovascular repair

- Capable of giving informed consent and willingness to comply with follow up
schedule

2. Anatomic Inclusion Criteria

- Presence of at least one of the following aneurysms is necessary to drive the
need for a repair with a fenestrated/branched device:

1. A thoracoabdominal aortic aneurysm ≥ 4 cm or suggestive of a high risk of
rupture as a result of morphology, growth history or symptoms

2. A renal artery aneurysm > 20 mm (or twice the diameter of native renal
artery)

3. An SMA aneurysm >30 mm

- Outside of the "Indications for Use" for commercially available fenestrated or
branched endografts approved for use for the treatment of these aneurysms.

- Proximal neck

1. Diameter ≤ 40 mm, ≥20 mm

2. Proximal neck length ≥ 10mm.

3. The proximal landing zone may be in a prior endograft or a prior surgical
graft.

- Iliac Artery

1. Diameter ≥ 7 mm (anticipated diameter following balloon angioplasty,
stenting, dottoring, or conduit) or ≥ 6 mm for patients receiving an
Low-Profile device.

2. Iliac angulation that will not preclude device delivery or surgical
modification of the iliac system

3. For a bifurcated or aorto-monoiliac prosthesis, iliac implantation sites
require ≤ 20 mm in diameter and ≥ 20 mm in length

- For a straight aorto-aortic prosthesis, distal neck (normal aorta between the
aneurysm and iliac bifurcation) ≥ 10 mm in length and ≤ 40 mm in diameter

- If a hypogastric branch will be used to treat the common iliac aneurysm

1. The intended common iliac artery is > 20mm in diameter or the aneurysm has
morphology concerning for rupture; and

2. The intended distal fixation site within the internal iliac is ≤ 10mm in
diameter.

- Renal arteries or other visceral vessels arising from the aorta in an orientation
that is evident and measurable from cross-sectional imaging (CT or MR)

- Visceral branch diameters (for incorporated vessels) between 4 mm - 11 mm at the
intended distal sealing site (thus distal to a visceral artery aneurysm in such
circumstances).

- Greater than 5 mm of proximal visceral branch length to allow for a seal with the
mated device, or the ability to exclude an early branch.

- In the setting of an aortic dissection the following criteria must exist:

1. Access into the true lumen from the groin and at least one supra-aortic
trunk vessel

2. A sealing zone in the target aorta (or surgical graft) that is proximal to
the primary dissection, such that a stentgraft would be anticipated to seal
off the dissection lumen

3. A sealing zone in the target supra-aortic trunk vessels that is distal to
the dissection, anticipated to seal off the dissection lumen, or surgically
created

4. A true lumen size large enough to deploy the device and still gain access
into the target branches

- In the setting of a more proximal disease, the repair may be coupled with an
arch-branched device, thoracic aortic endograft, or surgical aortic repair -
typically performed in a staged fashion

General Exclusion Criteria

1. Patient can be treated in accordance with the instructions for use with a commercially
marketed endovascular prosthesis

2. Pregnancy

3. History of anaphylactic reaction to contrast material with an inability to properly
prophylax the patient appropriately

4. Known sensitivity or allergy to materials of construction of the device (including the
materials of the LP device).

5. Body habitus that would inhibit X-ray visualization of the aorta

6. Subject had a major surgical or interventional procedure unrelated to the treatment of
the aneurysm planned <30 days from the endovascular repair

7. Unstable angina

8. Unwilling to comply with follow up schedule

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

10. An uncorrectable coagulopathy