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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P020018 S010/ PAS001 |
| Date Original Protocol Accepted |
09/07/2006
|
| Date Current Protocol Accepted |
09/07/2006
|
| Study Name |
AAA Flex 36mm
|
| Device Name |
36 MM DIAMETER ZENITH FLEX AAA ENDOVASCULAR GRAFT
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The Australian study is a multi-center, non-randomized prospective clinical study, with six Australian sites participating. The U.S. physician sponsored pre market study is a single center, non-randomized retrospective study. The plan is to assess patients from both studies for a total duration of five years.
|
| Study Population |
Patients who were implanted with the device in the original study, with an abdominal aortic aneurysm or aortic-ileac aneurysm of at least 5 cm or expanding at a rate of at least 0.5 cm per year, who does not meet the study's exclusion criteria.
|
| Sample Size |
15 Austrailian and 26 US patients
|
| Key Study Endpoints |
Endpoints include: 1) adverse events, 2) endoleaks, 3) secondary interventions, 4) aneurysm enlargement, 5) rupture, 6) conversion, and 7) aneurysm-related death.
|
| Follow-up Visits and Length of Follow-up |
Length of follow-up is five years. Patients will be followed on an annual basis.
|
| Interim or Final Data Summary |
| Interim Results |
The size of the postapproval study making the power of the study to detect a high rate of aneurysm-related deaths low. However, the consensus of the FDA review team is that the confidence in the safety and effectiveness of this device is high because the only modification from the previous approved device is an enlargement of the size. Furthermore, the study was approved with full knowledge that the sample size would be small, no aneurysm-related deaths have been reported to this date, and because the device is rarely used it would be very difficult to recruit substantial new cases at this time.
|
| Actual Number of Patients Enrolled |
41
|
| Actual Number of Sites Enrolled |
8
|
| Patient Follow-up Rate |
18% through five years
|
| Final Safety Findings |
There were no aneurysm-related deaths or conversions to open surgery. There was one ruptured aneurysm which occurred within the first year post implant..
|
| Final Effect Findings |
There were no cases of device migration, and aneurysms were far more likely to shrink than grow in size during the course of the study.
|
| Study Strengths & Weaknesses |
Follow-up rate was very poor. That plus the fact that the study was very small to begin with means that the data were too sparse to make any definitive conclusions.
|
| Recommendations for Labeling Changes |
None. The data from this study do not change current knowledge of device performance
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