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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P020004 / PAS001 |
| Date Original Protocol Accepted |
11/06/2002
|
| Date Current Protocol Accepted |
|
| Study Name |
PAS
|
| Device Name |
EXCLUDER BIFURCATED ENDOPROSTHESIS
|
| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The 98-03 study was a multi-center (19 sites), nonrandomized, prospective, concurrent controlled trial, which compared standard open surgical repair (n=99) to endovascular treatment with the EXCLUDER (n=235). The 99-04 study was designed to compare the modified EXCLUDER device to surgical controls with respect to safety and to the original EXCLUDER device with respect to effectiveness. One hundred and ninety three (193) subjects were enrolled between April 2000 and April 2001. Eighty eight (88) additional subjects were enrolled in the continued access protocol
|
| Study Population |
Subjects implanted with the Gore EXCLUDER device.The EXCLUDER Bifurcated Endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysms disease and who have appropriate anatomy inluding: 1) adequate iliac/femoral access, 2) infrarenal aortic neck treatment diameter range of 19-26 inm and a minimum aortic neck length of 15 nim, 3) proximal aortic neck angulation greater than or equal to 60 degrees, and 4) Iliac artery treatment diameter range of 8-13.5 mm and iliac distal vessel seal zone length of at least 10 mm
|
| Sample Size |
565 patients, 99 surgical controls
|
| Key Study Endpoints |
The primary clinical endpoints included major adverse events and major device events.
|
| Follow-up Visits and Length of Follow-up |
Follow-up at 1-month, 3-months, 6-months, 12 months, and annually thereafter, for a total of 5 years.
|
| Interim or Final Data Summary |
| Interim Results |
Study completed, see final results.
|
| Actual Number of Patients Enrolled |
565 patient
|
| Actual Number of Sites Enrolled |
19 or more sites
|
| Patient Follow-up Rate |
73%
|
| Final Safety Findings |
The final analysis showed 81% survival at 5 years in the control group and 70% survival in the combined pre-market cohort. Survival from aneurysm-related mortality at 5 years was 98% in both groups, with no statistically significant difference.
|
| Study Strengths & Weaknesses |
The strengths of the study included the prospective cohort study and concurrent control group.
|
| Recommendations for Labeling Changes |
None
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