|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P020004 S006/ PAS001 |
Date Original Protocol Accepted |
06/02/2004
|
Date Current Protocol Accepted |
06/02/2004
|
Study Name |
Long Term Follow up
|
Device Name |
EXCLUDER BIFURCATED ENDOPROTHESIS
|
General Study Protocol Parameters |
Study Design |
Prospective & Retrospective Study
|
Data Source |
New Data Collection
|
Comparison Group |
Historical Control
|
Analysis Type |
Analytical
|
Study Population |
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
The study is a multi-site, non-randomized, combination prospective and retrospective observational cohort study to evaluate the performance of the Gore Excluder abdominal aortic anuerysm Endoprosthesis Low Permeability device in the primary treatment of infrarenal abdominal aortic aneurysms. This evaluation will assess the incidence of aneurysm volume increase and morphology over time in subjects treated with the device.
|
Study Population |
Patients were randomly selected from the 98-03 Pivotal Trial who were treated with the original GORE EXCLUDER device and had a CT scan performed at 24 months
|
Sample Size |
140 subjects and 120 controls, 9 sites
|
Key Study Endpoints |
Device related adverse events, aneurysm diameter, aneurysm volume, death, and conversions.
|
Follow-up Visits and Length of Follow-up |
Endpoints are to be assessed at are to be assessed at baseline, post-procedure, at one month, six months, one year and two years post-procedure.
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Interim or Final Data Summary |
Interim Results |
Study completed, see final results.
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Actual Number of Patients Enrolled |
139 patients
|
Actual Number of Sites Enrolled |
8 sites
|
Patient Follow-up Rate |
89%
|
Final Safety Findings |
The final analysis showed very good device performance
|
Study Strengths & Weaknesses |
Weakness: 1) Combination of retrospective and prospective data made interpretation somewhat difficult; 2) Small number of sites; Strength: Subjects and controls were well matched.
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Recommendations for Labeling Changes |
None
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