Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices

Endovascular repair of complex aortic aneurysms is limited by the need to maintain blood flow
to the critical organs that receive blood from the aorta, such as the kidneys, liver and
intestines. While there are some commercially available devices that may treat some of these
patients these devices may not be suitable or available for a given patient. In this study we
will use custom made devices manufactured by Cook, Inc, Zenith t-Branch devices and
off-the-shelf, FDA approved devices which are altered by creating fenestrations (holes) in
the stent graft that allow additional stents to be inserted into the blood vessels that
supply blood to these critical organs.

Determination of which type of endograft to use will be based on the patient's anatomy and
the perceived urgency of the need for repair. This decision will be made by the study team
and confirmed by a 3rd party reviewer who is not an investigator on the study team. After
ensuring that a patient meets inclusion and exclusion criteria for participation in the
CARPE-CMD study, the perceived urgency for repair will be evaluated given the 8-10 week
required time for manufacture of a CMD device.

If the patient's aneurysm is not symptomatic and if, at the discretion of the treating
surgeon, the patient is deemed safe to wait 8 weeks until repair, the patient will be
considered non-urgent. Non-urgent patients will undergo repair with a CMD device.

If the patient's aneurysm is symptomatic and if, at the discretion of the treating surgeon,
the patient is deemed unsafe to wait 8 weeks until repair, the patient will be considered
urgent. Urgent patients will undergo repair with a t-branch device (if anatomy suitable) if
they are deemed safe to wait for the device to be obtained (<72 hours). Urgent patients who
do not have anatomy suitable to a t-branch device or patients who are not deemed safe to wait
for the device to be obtained, will undergo repair with a physician modified device.

The device is inserted into the body through two small punctures or incisions in the groin.
Small stents will be inserted through the stent graft fenestrations into the major blood
vessels affected by the aneurysm so that blood flow is maintained to these organs.

Inclusion Criteria:

- A patient may be suitable for inclusion in the study if the patient has at least one
of the following:

1. Aortic or aortoiliac aneurysm with diameter ≥5.5 cm

2. Aortic or aortoiliac aneurysm with a history of growth ≥1.0 cm per year, or
clinical indication for aneurysm repair based on symptoms

General Inclusion Criteria

1. Cannot be treated with a currently available non-modified approved device

2. Symptomatic on presentation and unsafe to wait for the time necessary to obtain a
currently available non-modified approved device

3. At least 18 years of age

4. Not pregnant or breastfeeding

5. Willing and able to comply with five years of follow-up

6. Willing and able to provide informed consent prior to enrollment

7. No systemic or local infection that may increase the risk of endovascular graft
infection

8. High risk for open surgical repair based on any of the factors below:

a. Anatomic i. Previous abdominal surgery ii. Previous left-sided thoracotomy (if
the proposed open repair would require dissection of the thoracic aorta) iii.
Previous aortic surgery b. Physiologic i. ASA Category III or higher ii. Age >70
years iii. Current tobacco use iv. Previous myocardial infarction, coronary
artery disease, or coronary artery stent v. Coronary stress test with a
reversible perfusion defect vi. Congestive heart failure vii. COPD

Exclusion Criteria:

- Exclusion Criteria Medical Exclusion Criteria 1. Cultural objection to receipt of
blood or blood products 2. Allergy or sensitivity to stainless steel, polyester,
polypropylene, solder (tin, silver), gold, or nitinol 3. Anaphylactic reaction to
contrast that cannot be adequately pre-medicated 4. Uncorrectable coagulopathy 5.
Unstable angina (defined as angina with a progressive increase in symptoms, new onset
at rest or nocturnal angina, or onset of prolonged angina) 6. Patient has a major
surgical or interventional procedure planned ≤30 days of the aneurysm repair 8.
Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos
syndrome) 9. Patient has active malignancy 10. Patient has life expectancy less than
two years

Anatomical Exclusion Criteria

1. Significant occlusive disease, tortuosity, or calcification that would prevent
endovascular access

2. Proximal neck length ≤25 mm

3. Proximal neck, measured outer wall to outer wall on a sectional image (CT)

1. For use of Zenith Flex: diameter >32 mm or <18 mm

2. For use of Zenith TX2: diameter >38 mm or <24 mm (for proximal and distal neck
diameter)

4. Proximal neck angulated more than 60 degrees relative to the long axis of the aneurysm

5. Proximal neck diameter change over the length of the proximal seal zone >4 mm

6. Proximal seal site with a circumferential thrombus/atheroma

7. Iliac artery diameter, measured inner wall to inner wall on a sectional image (CT)
<7.0 mm at any point along access length (prior to deployment)

8. Ipsilateral iliac artery fixation site diameter, measured inner wall on a sectional
image (CT) >21 mm at distal fixation site

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

10. Non-bifurcated segment of any artery to be stented < 15 mm in length

11. Artery to be stented with a maximum diameter <3 mm or >10 mm at the vessel ostium

12. Inability to maintain at least one patent hypogastric artery