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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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AVeVA Continued F/U Post-Approval Study


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General
Study Status Study Pending
Application Number P170042 / PAS001
Study Name AVeVA Continued F/U 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 Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of the AVeVA study is to evaluate the long-term safety and effectiveness of the Covera Vascular Covered Stent. It is a prospective, multi-center, non-randomized, single-arm clinical study and involves continued follow-up of the premarket cohort.
Study Population Description The study population is patients dialyzing with an AV graft that have a stenoses at the venous anastomosis.
Sample Size A total of 110 subjects are enrolled in the study.
Data Collection Clinical outcomes at 12, 18, and 24 months will include target lesion primary patency, access circuit primary patency, secondary patient, total number of target lesion reinterventions and access circuit reinterventions, index of patency function, index of patency function – target lesion, and rate of device and procedure related adverse events.
Follow-up Visits and Length of Follow-up 2 years


AVeVA Continued F/U Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 07/30/2019   Overdue
two year report 07/29/2020    
three year report 07/29/2021    
four year report 07/29/2022    


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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