Ensayos clínicos

Inclusion Criteria

• Abdominal Aortic Aneurism 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.

Eligibility last updated 6/13/22. Questions regarding updates should be directed to the study team contact.