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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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PAS1 - PostMarket Surveillance-Long Term Safety


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General
Study Status Protocol Overdue
Application Number P170032 / PAS001
Date Current Protocol Accepted  
Study Name PAS1 - PostMarket Surveillance-Long Term Safety
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of the trial is to collect long-term safety and effectiveness information on the WovenEndobridge (WEB) Aneurysm Embolization System in the endovascular treatment of wide-necked aneurysms located at the middle cerebral artery (MCA) bifurcation, internal carotid artery (ICA) terminus, anterior communicating artery (AComm) complex, or basilar artery apex.
Study Population Description Subjects with wide-necked intracranial aneurysms located at the at the middle cerebral artery (MCA) bifurcation, internal carotid artery (ICA) terminus, anterior communicating artery (AComm) complex, or basilar artery apex.
Sample Size 150 Subjects Enrolled
Data Collection For effectiveness the hypothesis is that the proportion of subjects with complete aneurysm occlusion without retreatment, recurrent subarachnoid hemorrhage, without significant parent artery stenosis (>50% stenosis) at one year after treatment. For safety, the hypothesis is the proportion of subjects with death of any nonaccidental cause or any major stroke (defined as an ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the National Institutes of Health Stroke Scale) within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to one year after treatment.
Follow-up Visits and Length of Follow-up 5 years


PAS1 - PostMarket Surveillance-Long Term Safety Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 07/01/2019 06/27/2019 On Time
one year report 12/31/2019    
18 month report 06/30/2020    
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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