Endurant Evo US Clinical Trial

The clinical evidence collected as part of this trial will be used in conjunction with data
collected during the concurrently enrolling Endurant Evo International Clinical Trial.

Inclusion Criteria:

1. Subject is ≥18 years old

2. Subject understands and voluntarily has signed and dated the Informed Consent approved
by the Sponsor and by the Ethics Committee/Institutional Review Board

3. Subject is able and willing to comply with the protocol and to adhere to the follow-up
requirements

4. Subject is a suitable candidate for elective surgical repair of AAA as evaluated by
American Society of Anesthesiologists (ASA) Physical Status Classification System I,
II, or III

5. Subject has an infrarenal abdominal aortic or aortoiliac aneurysm characterized by one
or more of the following:

- Aneurysm is >5 cm in diameter (diameter measured is perpendicular to the line of
flow)

- Aneurysm is 4 - 5 cm in diameter and has increased in size ≥0.5 cm within the
previous 6 months

6. Subject meets all the following anatomical criteria as demonstrated on
contrast-enhanced CT or

MRA imaging:

- Proximal neck length of ≥ 10 mm with ≤ 60° infrarenal and ≤ 45° suprarenal neck
angulation or Proximal neck length of ≥ 15 mm with ≤ 75° infrarenal and ≤ 60°
suprarenal neck angulation

- Subject has vascular dimensions, e.g., aortic and iliac diameters, lengths from renal
arteries to iliac bifurcation and hypogastric arteries, in the range of sizes
available for the Endurant Evo AAA stent graft system (measured intima to intima) and
within the sizing recommendations (refer to Endurant Evo AAA stent graft system
Instructions for Use (IFU))

- Subject has a proximal aortic neck diameter ≥ 18 mm and ≤ 32 mm

- The distal fixation center of the iliac arteries must have a diameter ≥ 7 mm and ≤ 25
mm bilaterally for the bifur and unilaterally for the AUI

- Subject has documented imaging evidence of at least one patent iliac and one femoral
artery, or can tolerate a vascular conduit that allows introduction of the Endurant
Evo AAA stent graft system

- Subject has distal non-aneurysmal iliac (cylindrical) fixation length ≥20 mm bilateral
for the bifur and unilaterally for the AUI

Exclusion Criteria:

1. Subject has a life expectancy ≤1 year

2. Subject is participating in another investigational drug or device study which would
interfere with the endpoints and follow-ups of this study

3. Subject is pregnant

4. Subject has an aneurysm that is:

- Suprarenal/pararenal/juxtarenal

- Isolated ilio-femoral

- Mycotic

- Inflammatory

- Pseudoaneurysm

- Dissecting

- Ruptured

- Leaking but not ruptured

5. Subject requires emergent aneurysm treatment

6. Subject has a known, untreated thoracic aneurysm >4.5 cm in diameter at the time of
screening

7. Subject has been previously treated for an abdominal aortic aneurysm

8. Subject has a history of bleeding diathesis or coagulopathy

9. Subject has had or plans to have an unrelated major surgical or interventional
procedure within 1 month before or after implantation of the Endurant Evo AAA stent
graft

10. Subject has had a myocardial infarction (MI) or cerebral vascular accident (CVA)
within 3 months prior to implantation of the Endurant Evo AAA stent graft

11. Subject has a conical neck defined as a >4 mm distal increase from the lowest renal
artery over a 10 mm length

12. Subject has a known allergy or intolerance to the device materials

13. Subject has a known hypersensitivity or contraindication to anticoagulants,
antiplatelets, or contrast media, which is not amenable to pre-treatment

14. Subject has significant aortic thrombus and/or calcification at either the proximal or
distal attachment centers that would compromise fixation and seal of the device at the
discretion of the investigator

15. Subject has ectatic iliac arteries requiring bilateral exclusion of hypogastric blood
flow

16. Subject whose arterial access site is not anticipated to accommodate the diameter of
the Endurant Evo AAA stent graft delivery system (13F-17F) due to vessel size,
calcification, or tortuosity

17. Subject is morbidly obese or has other documented clinical conditions that severely
inhibit radiographic visualization of the aorta at the discretion of the investigator

18. Subject has active infection at the time of the index procedure documented by e.g.
pain, fever, drainage, positive culture and/or leukocytosis considered to be
clinically significant per investigator discretion

19. Subject has congenital degenerative collagen disease, e.g., Marfan's Syndrome

20. Subject has a creatinine level > 2.00 mg/dl (or >176.8 μmol/L)

21. Subject is on dialysis