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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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AVeNEW PAS


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General
Study Status Ongoing
Application Number /
Requirement Number		 P170042 S002/ PAS002
Date Original Protocol Accepted 10/31/2019
Date Current Protocol Accepted  
Study Name AVeNEW PAS
Device Name Covera™ Vascular Covered Stent
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 objective of this study is to collect post-market, real-world safety and effectiveness data of the COVERA Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the AV access circuit.
This is a prospective, multi-center, non-randomized clinical study designed to assess the long-term safety and effectiveness of the COVERAVascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the AV access circuit of hemodialysis subjects dialyzing with an AV fistula.
Study Population All-comers population
Sample Size 100 subjects
Key Study Endpoints Safety through 30 days.
TLPP through 30 days, 90 days, 6 months, 12 months, 18 months, 24 months and 36 months.
ACPP through 30 days, 90 days, 6 months, 12 months, 18 months, and 24 months and 36 months.
Rate of device and procedure related AEs involving the AV access circuit through 90 days, 6 months, 12 months, 18 months, and 24 months and 36 months.
Total Number of AV Access Circuit Reinterventions through 30 days, 90 days, 6 months, 12 months, 18 months, and 24 months and 36 months.
Total Number of Target Lesion Reinterventions through 30 days, 90 days, 6 months, 12 months, 18 months, and 24 months and 36 months.
Index of Patency Function (IPF) evaluated at 30 days, 90 days, 6 months, 12 months, 18 months, and 24 months and 36 months.
Index of Patency Function – Target Lesion (IPF-T) evaluated at 30 days, 90 days, 6 months, 12 months, 18 months, and 24 months and 36 months.
Secondary Patency evaluated through 30 days, 90 days, 6 months, 12 months, 18 months, and 24 months and 36 months.
Acute Technical Success.
Acute Procedure Success (Anatomic and Clinical Success).
Follow-up Visits and Length of Follow-up All patients will receive 3 years of follow-up.


AVeNEW PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 08/30/2019 09/17/2019 Overdue/Received
1 year report 02/29/2020 03/02/2020 Overdue/Received
18 month report 08/29/2020 08/28/2020 On Time
2 year report 02/28/2021 03/01/2021 Overdue/Received
3 year report 02/28/2022 02/28/2022 On Time
4 year report 02/28/2023 02/23/2023 On Time
5 year report 02/28/2024 02/23/2024 On Time
6 year report 02/28/2025    
final report 03/30/2026    


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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