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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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PAS1 - PostMarket Surveillance-Long Term Safety


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General
Study Status Ongoing
Application Number /
Requirement Number		 P170032 / PAS001
Date Original Protocol Accepted 03/29/2021
Date Current Protocol Accepted  
Study Name PAS1 - PostMarket Surveillance-Long Term Safety
Device Name Woven EndoBridge (WEB) Aneurysm Embolization System
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 Objectives 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 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
Key Study Endpoints 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 Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 07/01/2019 06/27/2019 On Time
1 year report 12/31/2019 12/26/2019 On Time
18 month report 06/30/2020 06/29/2020 On Time
2 year report 12/30/2020 12/17/2020 On Time
3 year report 12/30/2021 12/23/2021 On Time
42 month report 06/30/2022 06/30/2022 On Time
4 year report 12/30/2022 12/22/2022 On Time
5 year report 01/31/2024 01/31/2024 On Time
6 year report 12/30/2024    


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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