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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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AVeNEW Study


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General
Study Status Study Pending
Application Number P170042 S002/ PAS001
Study Name AVeNEW Study
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of the AVeNew study is to evaluate the long-term safety and effectiveness of the Covera Vascular Covered Stent. It is a prospective, multi-center, randomized, concurrently controlled clinical study and involves continued follow-up of the premarket cohort to 3 years. In addition to continued follow up of the premarket cohort, an additional cohort of 100 subjects treated with the Covera device will also be studied through 3 years of follow up.
Study Population Description The study population is patients dialyzing with an AV fistula that have a stenoses in the venous outflow.
Sample Size A total of 280 subjects are enrolled in the study. An additional 100 subjects will be enrolled in the post approval study.
Data Collection Clinical outcomes at 30 days will include evaluation of safety, and at 90 days, 6, 12, 18, 24 and 36 months will include target lesion primary patency, access circuit primary patency, secondary patency, total number of target lesion reinterventions, 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 3 years


AVeNEW Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/30/2019   Overdue
one year report 02/29/2020    
18 month report 08/29/2020    
two year report 02/28/2021    
three year report 02/28/2022    


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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