In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
This is a multi-center, non-randomized, prospective observational study, designed to compare device users with historical
Study Population Description
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.
450 TAG subjects and 94 surgical control subjects, 35 sites
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.
Followup Visits and Length of Followup
Follow-up visits will be accomplished at discharge, 30 days post-implant, and annually thereafter, for a
total of five years.
Final Study Results
Actual Number of Patients Enrolled
449 overall (150 training study + 299 IDE participants)
Actual Number of Sites Enrolled
25 (in training study)
Patient Followup Rate
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 Effectiveness Findings
5쳌]year aneurysm쳌]related mortality rate = 94.7% 1 ruptured aneurysm (0.2%) 1 case of device migration (0.2%)
Study Strengths and Weaknesses
Strengths: Prospective cohort study; success criteria for primary endpoint met by large margin; concurrent control group. Weakness: