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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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ATLAS Study


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General
Study Status Progress Adequate
Application Number P180031 / PAS001
Study Name ATLAS Study
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 determine the long-term safety and effectiveness of the Atlas Stent System in the endovascular treatment of wide-necked intracranial aneurysms in the anterior circulation.
Study Population Description Subjects with a wide-necked intracranial aneurysm in the anterior circulation.
Sample Size 201 enrolled
Data Collection The primary efficacy endpoint as determined by the angiographic core lab, is the percent of subjects with 100% occlusion (Raymond Class 1) without clinically significant stenosis (defined as = 50% stenosis) of the parent artery based on core lab evaluation of the 12 month follow up angiogram and without any subsequent treatment at the target aneurysm at the 12 month follow-up visit. Safety success is achieved with a primary safety event rate significantly less than 20%
Follow-up Visits and Length of Follow-up 3 years


ATLAS Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/14/2019    
one year report 05/15/2020    
18 month report 11/13/2020    
two year report 05/15/2021    
three year report 05/15/2022    
four year report 05/15/2023    
five year report 05/14/2024    


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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