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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 Study


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General
Study Status Progress Adequate
Application Number P170042 S002/ PAS001
Date Current Protocol Accepted  
Study Name AVeNEW 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 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
Interim or Final Data Summary
Actual Number of Patients Enrolled 280
Actual Number of Sites Enrolled 24
Patient Follow-up Rate 199/280 completed 24 month follow-up. 85/280 completed 36 month follow-up (study extension)
Final Safety Findings The primary safety endpoint was a measure of safety through 30 days post-index procedure. The primary safety endpoint was evaluated against standard PTA alone. Freedom from protocol-defined primary safety events through 30 days post-index procedure was 95.0% in the COVERA™ group and 96.4% in the PTA group. This confirms noninferiority of the COVERA™device with respect to primary safety with a p-value of 0.0022.
Final Effect Findings The primary effectiveness endpoint was an effective measure based on Target Lesion Primary Patency (TLPP) at 6 months post-index procedure. To demonstrate clinically acceptable effectiveness, the primary effectiveness endpoint was evaluated against the rate of TLPP at 6 months for standard PTA alone. TLPP at 6 months post-index procedure using Kaplan-Meier analyses at Day 180 was 78.7% in the COVERA group and 47.9% in the PTA group. The primary effectiveness endpoint for superiority to PTA alone was met with a p-value of <0.001.
Study Strengths & Weaknesses Strengths: The COVERA device is safe and its risk profile is comparable to PTA. The COVERA device has a strong early benefit in significantly improving TLPP up to 36 months.

Weaknesses: At 36 months, the benefit of improved TLPP starts to diminish – at 36 months TLPP in the COVERA arm was 26.2% versus 13.2% in subjects with PTA. This benefit is not observed with regards to Access Circuit Primary Patency (ACPP) – ACPP in the COVERA arm was 2.4% versus 7.9% in the PTA treated subjects. The average number of reinterventions was equal in both treatment and control arms at 36 months (i.e. 5.5 procedures per subject). With regards to maintaining patency and avoiding reinterventions, the COVERA made a negligible long-term difference compared to plain PTA. The secondary patency rate at 36 months was actually marginally better for PTA at 97% versus 90% for PTA.

Recommendations for Labeling Changes A labeling update is needed to make physician users aware that the benefit in TLPP seen at six months does not persist at 36 months, and for ACPP and minimizing need for reinterventions, the COVERA did not appear to improve late outcomes compared to plain PTA.


AVeNEW Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/30/2019 09/17/2019 Overdue/Received
one year report 02/29/2020 03/02/2020 Overdue/Received
18 month report 08/29/2020 08/28/2020 On Time
final report 04/30/2021 04/30/2021 On Time


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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