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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00593814 |
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Date of registration:
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20/12/2007 |
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Primary sponsor: |
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Public title:
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GORE EXCLUDER® Endoprosthesis - Low Permeability in Treatment of Abdominal Aortic Aneurysms
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Scientific title:
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A Clinical Evaluation of the GORE EXCLUDER® Bifurcated Endoprosthesis - Low Permeability in the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms |
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Date of first enrolment:
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June 2005 |
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Target sample size:
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139 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00593814 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Contacts
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Name:
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Mark F Fillinger, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dartmouth-Hitchcock Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Infrarenal Abdominal Aortic Aneurysms less than 4.5 cm in diameter
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:
1. Mycotic or ruptured aneurysm
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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Aortic Aneurysm, Abdominal
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Intervention(s)
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Device: GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability
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Primary Outcome(s)
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Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure
[Time Frame: 2 years]
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Secondary Outcome(s)
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Device Efficacy Events
[Time Frame: 2 years]
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Secondary ID(s)
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AAA 04-04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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