f Post-Approval Studies (PAS) Database
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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 Ongoing
Application Number /
Requirement Number		 P190015 / PAS002
Date Original Protocol Accepted 07/31/2020
Date Current Protocol Accepted 10/30/2020
Study Name TREO Post Approval Study
Device Name TREO® Abdominal Stent-Graft System
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 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 All-comers population
Sample Size A minimum of 300 subjects will be enrolled.
Key Study Endpoints 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 Reporting Schedule

Reporting 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 11/03/2021 Overdue/Received
2 year report 05/04/2022 05/04/2022 On Time
3 year report 05/04/2023 05/04/2023 On Time
4 year report 05/03/2024 05/03/2024 On Time
5 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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