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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Cohort Study

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Study Status Completed
Application Number P040043 / PAS001
Date Current Protocol Accepted 08/31/2005
Study Name Cohort Study
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 Design Description This is a multi-center, non-randomized, prospective observational study, designed to compare device users with historical controls.
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.
Sample Size 450 TAG subjects and 94 surgical control subjects, 35 sites
Data Collection 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 Safety Information 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

Cohort Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 09/21/2005 10/07/2005 Overdue/Received
1 year report 03/23/2006 03/31/2006 Overdue/Received
18 month reports 09/21/2006 10/10/2006 Overdue/Received
2 year report 03/23/2007 04/13/2007 Overdue/Received
2 year annual report w/pas data 03/23/2007 04/19/2007 Overdue
42 month year report 09/22/2007 10/02/2007 Overdue/Received
3 year report 03/22/2008 03/31/2008 Overdue/Received
4 year report 03/22/2009 03/25/2009 Overdue/Received
5 year report 03/22/2010 03/25/2010 Overdue/Received
6 year report 03/22/2011 03/23/2011 Overdue/Received
7 year report 03/21/2012 03/21/2012 On Time
8 year report 03/22/2013 03/22/2013 On Time
amended final report 02/21/2014 02/21/2014 On Time
9 year report-FINAL REPORT 03/22/2014 01/24/2014 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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