|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P990020 / PAS001 |
Date Original Protocol Accepted |
09/28/1999
|
Date Current Protocol Accepted |
09/28/1999
|
Study Name |
Long term
|
Device Name |
ANEURX STENT GRAFT SYSTEM
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
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 |
The study was a multi-center prospective clinical trial that involved 19 sites. The first five subjects enrolled at each site were enrolled in the surgical arm of the study. All following sequential enrollments received the AneuRx stent graft.
|
Study Population |
Patients were candidate for surgical repair of an infrarenal aortic or aorto-iliac aneurysm.
|
Sample Size |
923 patients, 16 sties
|
Key Study Endpoints |
The primary endpoint was aneurysm related mortality at 5 years. Secondary endpoints included 1) Delivery success, 2) Deployment success, 3) Stent graft migration, measured by CT, angiography, ultrasound, or pathological analysis, 4) Aneurysm exclusion, evidence of blood flow around or through the stent graft into the aneurysm, 5) Stent graft patency, evidenced by CT, angiography, ultrasound or pathological analysis, 6) Device integrity, 7) Mechanical integrity, 8) Major morbidity (rupture, conversion, and major adverse events, and 9) Mortality.
|
Follow-up Visits and Length of Follow-up |
Follow-up was scheduled at 1 month, 6 months, and 1 year post-procedure, then every 6 months for the duration of the implant, up to 5 years.
|
Interim or Final Data Summary |
Interim Results |
Study completed, see final results.
|
Actual Number of Patients Enrolled |
931 patients
|
Actual Number of Sites Enrolled |
16 sites
|
Patient Follow-up Rate |
75%
|
Final Safety Findings |
Late aneurysm-related mortality accelerated in years 4 and 5 and was very high compared to open surgical controls.
|
Study Strengths & Weaknesses |
Strength: Prospective follow-up design; Weakness: A literature control group that lacked some important information was used as a comparison group for the primary endpoint.
|
Recommendations for Labeling Changes |
We recommended that labeling changes be made to reflect the high aneurysm-related mortality rate in later years. Review of the labeling change is currently being done.
|