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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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PAS2 - WEB-IT Study


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General
Study Status Progress Adequate
Application Number P170032 / PAS002
Study Name PAS2 - WEB-IT Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The object of this trial is to determine the long-term safety and effectiveness of the WEB Aneurysm Embolization Device in the treatment of wide-neck bifurcation aneurysms located in the middle cerebral artery (MCA) bifurcation, internal carotid artery (ICA) terminus, anterior communicating artery (AComm) complex, or basilar artery apex. Additionally, this study seeks to better understand the proportion of subjects experiencing death by neurological cause or disabling stroke ( defined as an ischemic or hemorrhagic stroke resulting in an mRS of 3 or more) within the first 30 days after treatment or disabling stroke or neurologic death from day 31 to I-year after treatment in both ruptured and unruptured aneurysms, rate of rebleed for ruptured aneurysms, occlusion rate as a proportion of subjects with adequate aneurysm occlusion without retreatment, or recurrent subarachnoid hemorrhage at one year after treatment, changes in the mRS, investigation of antiplatelet regimens for subjects with unruptured aneurysms, long-term stability defined as adequate occlusion outcomes with the WEB device, the effect of the marker recess on occlusion stability (WOS A versus B), imaging and clinical follow-up examination to be performed at 1-, 3- and 5-years post-procedure, and neurological deficits using validated neurological assessments such as the modified Rankin Scale (mRS) score and a patient reported outcome measure e.g. EQ-5D.
Study Population Description Subjects with an intracranial aneurysm located in the middle cerebral artery (MCA) bifurcation, internal carotid artery (ICA) terminus, anterior communicating artery (AComm) complex, or basilar artery apex eligible for endovascular treatment. Aneurysm characteristics should be saccular, wide neck, located at a bifurcation with dome diameter from 3 mm to 10 mm and either neck size 4 mm or greater or the dome-to-neck ratio is greater than 1 and less than 2.
Sample Size TBD
Follow-up Visits and Length of Follow-up 5 years


PAS2 - WEB-IT Study 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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