Clinical Trials

Inclusion Criteria

• Abdominal aortic aneurism (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 
• 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
• An Informed Consent Form (ICF) signed by Subject 
• Male or infertile female 
• Able to comply with Protocol requirements including following-up 
• Life expectancy > 2 years 
• Age ≥ 21 years

Exclusion Criteria

• Mycotic or ruptured aneurysm 
• Known concomitant thoracic aortic aneurysm which requires surgical intervention
• Renal insufficiency defined as creatinine > 2.5 mg/dL or patient undergoing dialysis 
• New York Heart Association (NYHA) class IV 
• Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s) 
• Severely tortuous or stenotic iliac and / or femoral arteries 
• Patient has body habitus or other medical condition which prevents adequate delineation of the aorta 
• Participating in another investigational device or drug study within 1 year of treatment 
• Systemic infection which may increase the risk of endovascular graft infection 
• Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome 
• Planned concomitant surgical procedure or major surgery within 30 days of treatment date 
• Known history of drug abuse 
• Known sensitivities or allergies to the device materials