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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-THRIVE Trial


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General
Application Number P070007 / PAS001
Current Plan Approved 04/05/2016
Study Name OSB Lead-THRIVE Trial
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study will examine the post-market performance of the Talent Thoracic Stent Graft System. This study is a prospective non-randomized 5 year trial. A total of 451 subjects will be analyzed that consists of 195 enrolled subjects from the VALOR Test Group of the Talent Thoracic PMA Submission, and 256 new subjects to be enrolled following PMA approval.

Study Population Description For purposes of cohort comparability, the inclusion/exclusion criteria will match to those used for the VALOR study with the exception of the removal of the following two parameters from the exclusion criteria: the patient's access vessel (as determined by treating physician) precludes safe insertion of the delivery system and patient requires a planned aortic conduit. Patients diagnosed with a descending thoracic aortic aneurysm are considered candidates for the endovascular repair. ,
Sample Size 195 subjects from the VALOR Test Group of the Talent Thoracic PMA Submission, and 256 new implants, 26 sites
Data Collection The primary endpoint of this study is freedom from aneurysm-related mortality at 5 years. The postmarket performance of the Talent Thoracic Stent Graft System will be evaluated by comparing aneurysm-related mortality rates in patients implanted with the Talent Stent Graft System at 5 years versus the rate at 1 year for open surgery. The open surgery aneurysm-related mortality rate is based on the experience collected in 3 Centers of Excellence. Aneurysm-related mortality is defined as: Death from rupture of the thoracic aortic aneurysm or from any procedure intended to treat the descending thoracic aorta
Follow-up Visits and Length of Follow-up The planned follow-up is 5 years for #2002-07. Participants from the #99-03 study will be followed until the termination of the post-approval study.
Final Study Results
Interim Safety Information The primary endpoint, aneurysm-related mortality, appears to be well within the range the success criteria for this study, with a rate of only 5.2% in the first year and only one case in subsequent years. 2. Other aneurysm-related events likewise pose no cause for concern at this time. There has been only one aneurysm rupture, one conversion to open surgery, and three interventions for endoleaks since the last report, six months ago. Increase in aneurysm size has remained at or below 10% for all five years of follow-up, and in each year of follow-up, the percent of subjects with a decrease in aneurysm size has outnumbered those with an increase by at least four times.


OSB Lead-THRIVE Trial Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 12/04/2008 12/05/2008 Overdue/Received
1 year report 06/05/2009 06/03/2009 On Time
18 month report 12/04/2009 12/04/2009 On Time
2 year report 06/05/2010 06/03/2010 On Time
3 year report 06/05/2011 06/03/2011 On Time
4 year report 06/04/2012 06/04/2012 On Time
5 year report 06/04/2013 06/04/2013 On Time
6 year report 06/04/2014 06/02/2014 On Time
7 year report 06/04/2015 05/29/2015 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
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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