Post-Approval Studies (PAS) Database

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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Training Study

General
Study Status	Completed
Application Number / Requirement Number	P040043 / PAS002
Date Original Protocol Accepted	08/31/2005
Date Current Protocol Accepted	08/31/2005
Study Name	Training Study
Device Name	GORE TAG THORACIC ENDOPROSTHESIS
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	New Data Collection
Comparison Group	No Control
Analysis Type	Descriptive
Study Population	Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives	This is an observational, multi-site, one armed prospective cohort study of patients with aneurysms treated with the TAG device.
Study Population	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	150 patients from 25 sites
Key Study Endpoints	The incidence of major adverse events at 30 days post-implant. Major Adverse Event are defined as those requiring therapy and short hospitalization (24-48 hours), major therapy, unplanned increase in level of care, prolonged hospitalization, permanent adverse sequelae, or death.
Follow-up Visits and Length of Follow-up	Patients are evaluated at 30 days post-implant.
Interim or Final Data Summary
Interim Results	Study completed, see final results.
Actual Number of Patients Enrolled	150 patients
Actual Number of Sites Enrolled	25 sites
Patient Follow-up Rate	100%
Final Safety Findings	All success criteria were met
Study Strengths & Weaknesses	Strength: Very good patient follow-up; Data collection was complete
Recommendations for Labeling Changes	None

Training Study Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
4 year report	03/22/2009	03/25/2009	Overdue/Received

Contact Us

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Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background