Expired Study
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Chicago, Illinois 60611


Purpose:

The safety and efficacy for the large diameter 31mm EXCLUDER will be superior to surgical repair and comparable to that of the approved EXCLUDER device.


Study summary:

The primary objective of this study is 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 to compare device performance of the original GORE EXCLUDER® AAA Endoprostheses to the 31mm EXCLUDER when used in the treatment of infrarenal abdominal aortic aneurysms will also be performed.


Criteria:

Inclusion 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 Exclusion Criteria: - 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


NCT ID:

NCT00615069


Primary Contact:

Principal Investigator
Jon S Matsumura, M.D.
Northwestern University


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60611
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 18, 2018

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