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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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SVS VQI Postmarket Surveillance Study


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General
Study Status Study Pending
Application Number P180001 / PAS002
Study Name SVS VQI Postmarket Surveillance Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description New enrollment under the SVS VQI Dissection Project, which will be referred to as the Zenith Dissection Endovascular System Post Approval Study. The objective of this study is to obtain long-term follow-up and additional information regarding the treatment of all types of dissections and reasons for repair.
Study Population Description Patients with acute or chronic dissections.
Sample Size 120 new patients with acute Type B dissections, who are treated using both the Zenith TX2 Dissection Endovascular Graft with Pro-Form and the Zenith Dissection Endovascular Stent, and 60 new patients with chronic Type B dissections, who are treated using the Zenith Dissection Endovasular System, will be included in the Zenith Dissection Endovascular System Post Approval Study.
Data Collection The endpoints for the Zenith Dissection Endovascular System Post Approval Study are the following:

Primary safety: Freedom from dissection-related mortality (all devices combined endpoint)

Primary effectiveness: device technical success and device procedural success at 30 days (device-specific endpoints)

Secondary endpoints: elements of device technical (during the procedure) and procedural success (30-day) for each project device; additional endovascular and surgical dissection-related interventions (30days, 1 year, yearly through 5-years); dissection treatment success and the individual elements of the composite endpoint dissection treatment success (30 days, 1 year, yearly through 5-years)
Follow-up Visits and Length of Follow-up 30-days, 1-year and yearly through 5 years


SVS VQI Postmarket Surveillance Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 12/31/2019    
two year report 12/30/2020    
three year report 12/30/2021    
four year report 12/30/2022    
five year report 12/30/2023    


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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