GORE EXCLUDER® Endoprosthesis - Low Permeability in Treatment of Abdominal Aortic Aneurysms
NCT ID: NCT00593814
Last Updated: 2018-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
139 participants
INTERVENTIONAL
2005-06-30
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability
Implant
Eligibility Criteria
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Inclusion Criteria
2. Anatomy meets EXCLUDER Bifurcated Endoprosthesis - Low Permeability specification criteria per Instructions for Use
3. Access vessel able to receive 18 French introducer sheath
4. Life expectancy \> 2 years
5. Appropriate candidate for endovascular repair
6. Ability to comply with protocol requirements including follow-up
7. 21 years of age or older, male or infertile female\*\*
Exclusion Criteria
2. Participating in another investigational device or drug study within one year
3. Documented history of drug abuse within six months
4. Myocardial infarction or cerebral vascular accident within six weeks
5. Pulmonary insufficiency requiring chronic home oxygen or inability to ambulate due to pulmonary function
6. Iliac anatomy that would require occlusion of both internal iliac arteries
7. Planned occlusion or reimplantation of significant mesenteric or renal arteries
8. Planned concomitant surgical procedure or previous major surgery within 30 days
9. Previous prosthesis placement in the aorta or iliac arteries
10. Degenerative connective tissue disease (e.g., Marfan's and Ehlers Danlos Syndrome)
18 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Responsible Party
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WL Gore & Associates
Principal Investigators
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Mark F Fillinger, MD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Other Identifiers
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AAA 04-04
Identifier Type: -
Identifier Source: org_study_id
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