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Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis for the Treatmentof Common Iliac Artery Aneurysms or Aorto-iliac Aneurysms.

Description

The primary objective of this study was to estimate the safety of the 31 mm GORE EXCLUDER® AAA Endoprosthesis as compared to open surgical repair when used in the treatment of infrarenal abdominal aortic aneurysms. A secondary objective was to compare device performance of the original GORE EXCLUDER® AAA Endoprosthesis to the 31mm EXCLUDER when used in the treatment of infrarenal abdominal aortic aneurysms.

Phase

N/A

Inclusion and Exclusion Criteria

  • Infrarenal AAA > or equal to 4.5 cm in diameter
  • Proximal infrarenal aortic neck length > or equal 15mm
  • Anatomy meets 31mm EXCLUDER specification criteria
  • Access vessel able to receive 20 Fr. introducer sheath
  • Life expectancy >2 years
  • Surgical candidate
  • ASA Class I, II, III, or IV
  • NYHA Class I, II, III
  • 21 years of age or older
  • Male or infertile female
  • Ability to comply with protocol requirements including follow-up
  • Signed Informed Consent Form

  • Mycotic or ruptured aneurysm
  • Participating in another investigational device or drug study within 1 year
  • Documented history of drug abuse within 6 months
  • Coexisting thoracic aortic aneurysm (50% larger than proximal aorta)
  • Myocardial infarction or cerebral vascular accident within 6 weeks
  • Pulmonary insufficiency requiring chronic home oxygen therapy or inability to ambulate due to pulmonary function
  • Renal insufficiency (Creatinine > 2.5 mg/dL) without dialysis
  • Iliac anatomy that would require occlusion of both internal iliac arteries
  • "Planned" occlusion or reimplantation of significant mesenteric or renal arteries
  • "Planned" concomitant surgical procedure or previous major surgery within 30 days
  • Previous prosthesis placement in the same position of the aorta or iliac arteries
  • Degenerative connective tissue disease, e.g., Marfans and Ehlers Danlos Syndrome
  • Proximal neck angulation > 60 degrees
  • Presence of significant thrombus at arterial implantation sites

Sites

  • Montana

    • St. Vincent Healthcare, Billings, Montana, 59101
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