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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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Continued f/u of pivotal study


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General
Study Status Study Pending
Application Number P180001 / PAS001
Study Name Continued f/u of pivotal 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 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 Follow-up data on the surviving patients of the 73 enrolled in the IDE pivotal study will be reported in the Continued Follow-up of the Zenith Dissection Endovascular System Pivotal Study. 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 following endpoints will be reported through 5-years for the Continued Follow-up of the Zenith Dissection Endovascular System Pivotal Study: false lumen characteristics (i.e., diameter change, patency, and source of persistent flow), dissection-related deaths, aortic ruptures, aortic enlargements, extension of the dissection, major adverse events (i.e., paraparesis, paraplegia, new ischemia), losses of device integrity, and additional dissection-related interventions, including the reasons for the interventions.

Follow-up Visits and Length of Follow-up 5 years


Continued f/u of pivotal 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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