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

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