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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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TREO Post Approval Study


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General
Study Status Progress Adequate
Application Number P190015 / PAS002
Date Current Protocol Accepted 10/30/2020
Study Name TREO Post Approval Study
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 Design Description The TREO Post Approval Study is a multi-center, open label, single arm, prospective post approval study. The objective of the study is to collect real world safety and effectiveness outcomes of the TREO Abdominal Stent-Graft System in an all-comers population eligible for the endovascular treatment of AAA in routine clinical practice, with emphasis on subjects that experience a device stent-strut or barb fracture.
Study Population Description All-comers population
Sample Size A minimum of 300 subjects will be enrolled.



Data Collection The primary endpoints are stent fracture, barb separation, and secondary intervention for adverse events related to stent fracture or barb separation.



Additional endpoints will be collected and reported at each follow-up point through 5 years post procedure, including but not limited to the following: technical success, major adverse events, all-cause mortality, aneurysm-related mortality, aneurysm rupture, secondary interventions, conversion to open surgery, losses of device integrity, device occlusions, stenosis or kink, aneurysm enlargement (> 5 mm), stent graft migration (> 10 mm), all types of endoleaks, and other device-related events.



Follow-up Visits and Length of Follow-up 5 years


TREO Post Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/02/2020 11/03/2020 Overdue/Received
one year report 05/04/2021 05/03/2021 On Time
18 month report 11/02/2021    
two year report 05/04/2022    
three year report 05/04/2023    
four year report 05/03/2024    
five year report 05/03/2025    


Contact Us

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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