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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P020018 S005/ PAS001 |
| Date Original Protocol Accepted |
06/09/2005
|
| Date Current Protocol Accepted |
06/09/2005
|
| Study Name |
Postmarket Surveillance Registry
|
| Device Name |
ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Interim or Final Data Summary |
| Interim Results |
A low occurrence of deployment problems was reported. No problems were reported for over 90% of the cases in each deployment category. All 151 implanted Zenith Renu AAA Ancillary Grafts were deployed successfully (i.e., successful delivery and deployment of the device and successful removal of the delivery system). One hundred eleven (111) cases were identified with endoleaks prior to or during the procedure.
Of those cases with endoleak, 96 were proximal type I endoleaks. The vast majority of new endoleaks at follow-up have been identified as type II. The sponsor concludes that it is likely many had been previously overlooked, misidentified, or masked by other existing endoleaks during review at earlier time periods.
|
| Actual Number of Patients Enrolled |
151
|
| Actual Number of Sites Enrolled |
95
|
| Patient Follow-up Rate |
60%
|
| Final Safety Findings |
One case of Renu migration occurred at 36 months after implantation. One occlusion was identified at the 24-month time period.. Death beyond 30 days of the initial procedure occurred in 43 cases. Twenty-nine cases were determined to be unrelated to endovascular repair. Of the 14 remaining cases, 5 have been adjudicated as related to endovascular repair (i.e., procedure, technique, pre-existing graft, and/or Renu-related) and 9 are unable to be adjudicated due to insufficient information from the site (no additional information is able to be collected).
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| Final Effect Findings |
One hundred eleven (111) cases (73.5%) were identified with endoleaks prior to or during the procedure. Of those cases with endoleaks, 96 were proximal type I endoleaks. There were 26 new type II endoleaks at one month and one remained at 60 months.
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| Study Strengths & Weaknesses |
The sponsor reports that 91 patients reached an endpoint at 5 years. Although the follow-up rate therefore is only 60%, there are enough patients with 5 year endpoint information since the conditions only required 100 patients to be enrolled.. The study provides additional information that can be used for updated labeling.
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| Recommendations for Labeling Changes |
Yes. The labeling supplement should include a summary of the post-approval study design, results, and study strengths and limitations. In addition, sponsor should provide not only rates in the revised labeling, but reasons for secondary interventions and conversions, as well as contributing factors or causes of death. Finally, the labeling should highlight the endoleak data from the post-approval study.
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