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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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WRAP Registry


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General
Study Status Study Pending
Application Number /
Requirement Number		 P240023 / PAS002
Date Original Protocol Accepted 02/12/2025
Date Current Protocol Accepted  
Study Name WRAP Registry
Device Name WRAPSODY® Cell-Impermeable Endoprosthesis
Clinical Trial Number(s) NCT03644017 NCT04540302 NCT05062291 
General Study Protocol Parameters
Study Design Active Surveillance
Data Source Sponsor Registry
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 This study is a prospective, multicenter, observational study designed to collect clinical outcomes data from subjects who have been treated with the Merit WRAPSODY® Cell Impermeable Endoprosthesis.

The objective of this study is to expand and understand the safety and effectiveness of the Merit WRAPSODY® Cell Impermeable Endoprosthesis in a real-world North American population.
Study Population Subjects with stenosis or occlusion within the dialysis outflow circuit who meet the inclusion and exclusion criteria are intended to participate in this study. The eligibility criteria are kept to a minimum to better represent the subject profile treated in actual clinical practice without selecting sub-groups of particular low/high risk or excluding certain diseases or anatomies.
Sample Size Number of subjects: up to 250, with 125 enrolled at United States sites.
Number of sites: up to 25, with 15 located in the United States
Sites location: United States and Canada
Key Study Endpoints wo primary endpoints are proposed:

Primary Safety: Proportion of subjects without any localized or systemic safety events through 30 days that affect the access or venous outflow circuit and result in reintervention, hospitalization, or death

Primary Effectiveness: Target Lesion Primary Patency (TLPP) at 6 months
Secondary:

Key secondary endpoints include:
TLPP at months 12, 24, and 36
Access Circuit Primary Patency (ACPP) at months 6, 12, 24, and 36
Rates of procedure- and device- related adverse events
Rate of device observations and potential malfunctions or failures
Number of reinterventions at months 6, 12, 24, and 36 months
Follow-up Visits and Length of Follow-up Data will be collected from available medical records for at 30 days, 6 months, 12 months, 24 months, and 36 months.


WRAP Registry Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 02/12/2026    
2 year report 02/12/2027    
3 year report 02/12/2028    


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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