Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms

The study design is a prospective, nonrandomized, international, multicenter study comprised
of two parallel substudies. The total subject population will be 190 subjects with 80
subjects assigned to the Short Neck Substudy and 110 subjects to the High Neck Angulation
Substudy.

This clinical study will include fifty-six sites in the US. Each enrolled subject will
undergo periodic follow-up evaluations involving physical exams and contrast-enhanced
computed tomography (CT) scans at specific, protocol-defined intervals for a period of five
years following the GORE® EXCLUDER® Conformable AAA Endoprosthesis implant. Each Substudy
will be evaluated and reported independently from each other according to the Safety and
Effectiveness Endpoints. No comparative analyses between these substudies are planned.

Inclusion Criteria:

1. AAA meeting any of the following criteria:

- Maximum diameter ≥50 mm

- Rapid growth (>5 mm in a 6 month period)

- Non-ruptured AAA presenting with clinical symptoms

2. Adequate anatomy to receive the GORE® EXCLUDER® Conformable AAA Endoprosthesis,
including:

- Adequate iliac / femoral access

- Infrarenal aortic neck diameter 16-32 mm

- Infrarenal aortic neck length ≥10 mm

- Aortic neck angle ≤ 90˚

- Distal iliac artery seal zone ≥10 mm

- Iliac artery diameter 8-25 mm

3. An Informed Consent Form (ICF) signed by Subject

4. Male or infertile female

5. Able to comply with Protocol requirements including following-up

6. Life expectancy > 2 years

7. Age ≥ 21 years

Exclusion Criteria:

1. Mycotic or ruptured aneurysm

2. Known concomitant thoracic aortic aneurysm which requires surgical intervention

3. Renal insufficiency defined as creatinine > 2.5 mg/dL or patient undergoing dialysis

4. New York Heart Association (NYHA) class IV

5. Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)

6. Severely tortuous or stenotic iliac and / or femoral arteries

7. Patient has body habitus or other medical condition which prevents adequate
delineation of the aorta

8. Participating in another investigational device or drug study within 1 year of
treatment

9. Systemic infection which may increase the risk of endovascular graft infection

10. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome

11. Planned concomitant surgical procedure or major surgery within 30 days of treatment
date

12. Known history of drug abuse

13. Known sensitivities or allergies to the device materials