Study of the Large Diameter GORE EXCLUDER® AAA Endoprosthesis in Abdominal Aneurysms

Completed · Phase 2

Conditions studied: Aortic Aneurysm, Abdominal

In brief

The purpose of this study is to assess the safety and efficacy of the 31 mm GORE EXCLUDER® AAA Endoprosthesis in the treatment of infrarenal abdominal aortic aneurysms

Key facts

Study ID

NCT00615069

Run by

W.L.Gore & Associates

People needed

35

Starts

2006-05-01

Expected to finish

2014-06-01

Last updated by the study team

2015-04-14

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St. Vincent Healthcare — Billings, Montana, United States

Full record on ClinicalTrials.gov

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