|
|
| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS010001 / PSS001 |
| Date Original Plan Accepted |
04/26/2002
|
| Date Current Plan Accepted |
04/26/2002
|
| Study Name |
AneuRx Stent Graft System
|
| Device Name |
Aneurx stent graft system
|
| Root Document Number |
P990020
|
| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective observational cohort study to examine aneurysm-related mortality through long term follow-up
|
| Study Population |
Adult
|
| Sample Size |
19 sites
|
| Key Study Endpoints |
Primary endpoint: Aneurysm-related mortality
|
| Follow-up Visits and Length of Follow-up |
5 year length of follow-up; visits scheduled annually
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
931
|
| Actual Number of Sites Enrolled |
19
|
| Patient Followup Rate |
100%
|
| Final Safety Findings |
There are no statistically differences in freedom from death, rupture or surgical conversion between the registries and the IDE cohort. The rate for freedom from surgical conversaion in the registry is 95.7% and for IDE is 89.9%. Freedom from death in the registry is 78.4% and IDE is 71.8% Freedom of ARD in registry is 97.9% and the IDE is 96.9%. The rate of freedom fro surgical conversaion at four years in the registry is 98.6% and the IDE is 91.3%
|
| Final Effectiveness Findings |
The delivery success rate was 99.4% for the registry compared to 98.1% in IDE. Endoleak in the registry was significantly lower intra-operatively than for the IDE study. But for all subsequent time periods, there was no statistically significant difference between the IDE and the registry. For the increases in aneurysm diameter, except for the first year that the PS registry demonstrated significantly higher rates of increases in aneurysm diameter. No difference was found in subsequent years between IDE and registry. In terms of loss of device integrity, there was no difference between the results from IDE and the registry.
|
| Study Strengths and Weaknesses |
Strengths: Prospective study; National Death Index (NDI) used to achieve follow-up of vital status and cause of death on patients who were otherwise lost to f/u; Sufficiently large sample size, and good variety of different sites
Weakness: No concurrent control group
|
| Recommendations for Labeling Changes |
Recommended labeling change to reflect ARM results
|
