|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P040043 / PAS001 |
| Date Original Protocol Accepted |
03/23/2005
|
| Date Current Protocol Accepted |
08/31/2005
|
| Study Name |
Cohort Study
|
| Device Name |
GORE TAG THORACIC ENDOPROSTHESIS
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a multi-center, non-randomized, prospective observational study, designed to compare device users with historical controls.
|
| Study Population |
The study population will include subjects enrolled into the TAG pre-market studies (TAG 97-01, TAG 99-01, TAG 03-03, and TAG 04-02) and subjects enrolled into this study (TAG 05-02). In addition, the physician training program assessment portion of the study will enroll subjects diagnosed with aneurysm of the DTA who meet all inclusion/exclusion criteria. Patients previously treated with the commercially approved TAG device by a physician who has completed the GORE TAG Physician Training program may be retrospectively screened for enrollment into this study.
|
| Sample Size |
450 TAG subjects and 94 surgical control subjects, 35 sites
|
| Key Study Endpoints |
The primary objective of this study is to evaluate the long-term performance of the TAG device. The endpoints include: 1) 5-year aneurysm-related mortality rate, 2) Stroke, 3) Paraplegia and 4) Reintervention.
|
| Follow-up Visits and Length of Follow-up |
Follow-up visits will be accomplished at discharge, 30 days post-implant, and annually thereafter, for a total of five years.
|
| Interim or Final Data Summary |
| Interim Results |
Since the 4-year interim report, there have been no new cases of aneurysm-related mortality or no new endoleaks identified. Based on the data that was submitted, there are no trends that appear to be cause for concern.
|
| Actual Number of Patients Enrolled |
449 overall (150 training study + 299 IDE participants)
|
| Actual Number of Sites Enrolled |
25 (in training study)
|
| Patient Follow-up Rate |
78%
|
| Final Safety Findings |
Reintervention:
Twenty쳌]nine (29) (6% of total) required 31 secondary interventions with additional endoprosthesis implants. Three (3) of these resulted in surgical conversions.
30쳌]Day Events:
쳌]Major adverse event rate (requiring therapy and short hospitalization (24쳌]48 hours), major therapy, unplanned increase in level of care, prolonged hospitalization, permanent adverse sequelae, or death.) = 22%
쳌]Stroke= 3%
쳌]Paraplegia= 3%
|
| Final Effect Findings |
5쳌]year aneurysm쳌]related mortality rate = 94.7%
1 ruptured aneurysm (0.2%)
1 case of device migration (0.2%)
|
| Study Strengths & Weaknesses |
Strengths: Prospective cohort study; success criteria for primary endpoint met by large margin;
concurrent control group.
Weakness: Overall 5쳌]year attrition rate of 78%
|
| Recommendations for Labeling Changes |
Yes: Recommend update to reflect results of PAS
|
