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

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Continued f/u Valiant EVO Study


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General
Study Status Study Pending
Application Number P100040 S036/ PAS001
Study Name Continued f/u Valiant EVO 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 purpose of this study is to obtain longer-term follow-up on the use of the Valiant Navion Stent Graft System to treat descending thoracic aortic aneurysms. There will be no new patient enrollment for this study; instead, five-year follow-up will be reported on the surviving patients from the 100 subjects enrolled in the IDE study, in accordance with the IDE protocol.



Study Population Description Patients with descending thoracic aortic lesions who have appropriate anatomy.
Sample Size 100 patients were enrolled in this IDE. Follow-up data on the surviving patients will be reported in this PAS.
Data Collection Clinical outcomes will include aneurysm-related mortality, aneurysm rupture, aneurysm expansion, Type Ia endoleak, migration, Type III endoleak, re-intervention, device-related adverse events, and device integrity.
Follow-up Visits and Length of Follow-up 5 years


Continued f/u Valiant EVO Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 10/19/2019 10/15/2019 On Time
two year report 10/18/2020    
three year report 10/18/2021    
four year report 10/18/2022    


Contact Us

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

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