f Post-Approval Studies (PAS) Database
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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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VIVID Continued Follow-up Study


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General
Study Status Study Pending
Application Number /
Requirement Number		 P230021 / PAS001
Date Original Protocol Accepted 12/26/2023
Date Current Protocol Accepted  
Study Name VIVID Continued Follow-up Study
Device Name Duo Venous Stent System
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 A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives To evaluate the long-term safety and effectiveness of the Duo Venous Stent System. The study is a prospective, multi-center follow-up of the VIVID (G190030) that enrolled 162 subjects from 30 investigational sites in the United States and European Union.
Study Population All remaining subjects treated with Duo Venous Stent System in the VIVID trial active at the end of 12 months evaluation.

There is no comparator group for the continued follow-up study.
Sample Size One hundred and fifty two (152) active subjects from the VIVID IDE trial.
Key Study Endpoints Endpoints to be assessed at 24 and 36 months include:
• Freedom from clinically driven target lesion revascularization (CD-TLR)
• Primary patency
• Primary assisted patency
• Secondary patency
• Stent fracture, migration, and embolization
• Changes in CEAP, Villalta, VCSS pain score, and VEINES QOL
• Venous Ulcer Assessment
• Clinically driven target vessel revascularization (CD-TVR)
• Adverse Events
Follow-up Visits and Length of Follow-up 3 years


VIVID Continued Follow-up Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 06/25/2024    
1 year report 12/25/2024    
2 year report 12/25/2025    
3 year report 12/25/2026    
4 year report 12/25/2027    


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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