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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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VasQ Postmarket Surveillance Study


 
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General
Study Status Study Pending
522 Number / Requirement Number PS230004 / PSS001
Date Original Plan Accepted 06/05/2024
Study Name VasQ Postmarket Surveillance Study
Device Name Vasq
Root Document Number DEN220026 
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study
arms:
. Treatment arm: End to side fistula supported with VasQ
. Control: Standard of care end to side fistula
The objective is to address the 522 Study Questions listed in the 522 order and above in Section II.C.
Study Population Patients who are candidates for the creation of a new end-to-side surgical arteriovenous fistula (AVF), per VasQ IFU and investigator clinical
judgment.
Sample Size Number of subjects: 300 (1:1 randomization between treatment and control arm)
Assumptions for sample size estimation: Expected rate of patients with functional fistula at 20, 50, 100, 150, 180 days
Note: The sample size for this study was determined to be clinically meaningful and was specified in the appeal decision letter.
Number of sites: 18
Sites location: Not yet available
Key Study Endpoints Safety Endpoints
Primary: Comparable rate of access related complications (including major reintervention and cannulation related complications)
Effectiveness Endpoints
Primary: Time to clinically functional AVF post fistula placement, up to 6 months post fistula placement
. Time to functional patency is defined as the time, in days, to the first day of a 28-day period in which the study fistula was able to
be cannulated with two dialysis needles for at least 75% of dialysis sessions to achieve the prescribed dialysis. (Beathard et al Clin J
Am Soc Nephrol 13: 501–512, 2018)
. Primary efficacy analysis set – Patients who are already on dialysis at the time of fistula placement.
Secondary:
1. Access primary patency
2. Access assisted primary patency
3. Access cumulative (secondary) patency
4. Reinterventions rate
5. Post-intervention cumulative patency
6. Central Venous Catheter (CVC) dwell time
7. CVC removal rate
8. Time to clinically functional AVF, up to 12 months post procedure
9. Time to unassisted clinically functional AVF up to 6 months and
12 months follow up

Follow-up Visits and Length of Follow-up Length of Follow-up: 12 months
Follow-up Visits: 1, 3, 6, and 12 months


VasQ Postmarket Surveillance Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 12/05/2024    
1 year report 06/05/2025    
18 month report 12/05/2025    
2 year report 06/05/2026    
3 year report 06/05/2027    
4 year report 06/05/2028    
5 year report 06/05/2029    


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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