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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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PREMIER Post-Approval Study


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General
Study Status Study Pending
Application Number P100018 S015/ PAS001
Study Name PREMIER Post-Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The “Prospective Study on Embolization of Intracranial Aneurysms with the Pipeline™ Device” (PREMIER) study is a prospective, multi-center non-randomized clinical study evaluating safety and effectiveness outcomes in patients with small or medium wide-necked intracranial aneurysms measuring less than or equal to 12 mm who are treated with the Pipeline™ device. The study includes continued follow-up of the premarket cohort for up to three (3) years post-procedure.
Study Population Description The study enrolled patients with small or medium wide-necked intracranial aneurysms measuring =12 mm who were treated with the Pipeline™ device.
Sample Size Out of 197 consented patients, 141 patients were implanted with the Pipeline device.
Data Collection The primary safety endpoint is the rate of major or disabling strokes or neurological deaths.

The primary effectiveness endpoint is the rate of patients who have complete (100%) Raymond-Roy Class I intracranial aneurysm occlusion without clinically significant parent artery stenosis or retreatment of the target aneurysm.

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


PREMIER Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/15/2019    
one year report 12/14/2019    
18 month report 06/13/2020    
two year report 12/13/2020    
three year report 12/13/2021    
four year report 12/13/2022    


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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