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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Cont F/u of the IDE Study Subjects


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General
Study Status Ongoing
Application Number /
Requirement Number		 P190015 / PAS001
Date Original Protocol Accepted 05/04/2020
Date Current Protocol Accepted  
Study Name Cont F/u of the IDE Study Subjects
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 Adult: >21
Detailed Study Protocol Parameters
Study Objectives The purpose of the post approval study is to evaluate the long-term safety and effectiveness of the TREO® Abdominal Stent-Graft System. It is a prospective, multi-center, single-arm clinical study. It involves the long-term follow-up of the premarket cohort.
Study Population The study population is patients with an infrarenal abdominal aortic aneurysm who met the study selection criteria.

Sample Size A total of 158 subjects were enrolled in IDE Pivotal and Continued Access studies.
Key Study Endpoints 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 Subjects will be followed for 5 years, with the exception of subjects identified with fracture(s) within the first 5 years who will be offered follow-up for an additional 5 years (total of 10 years of follow-up).


Cont F/u of the IDE Study Subjects Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
interim report 05/03/2021 05/03/2021 On Time
1 year report 05/04/2021 05/03/2021 On Time
2 year report 05/04/2022 05/04/2022 On Time
3 year report 07/14/2023 07/14/2023 On Time
4 year report 05/03/2024    
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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