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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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Continued Follow-up Post-Approval Study


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General
Study Status Study Pending
Application Number /
Requirement Number
P240009 / PAS001
Date Original Protocol Accepted 10/11/2024
Date Current Protocol Accepted  
Study Name Continued Follow-up Post-Approval Study
Device Name Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection
Clinical Trial Number(s) NCT04201132 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives continued follow-up of premarket cohort
Study Population subjects at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below:
• Patients with symptomatic stenosis of the common or internal carotid artery with greater than or equal to 50% as determined by angiography using NASCET methodology OR Patients with asymptomatic stenosis of the common or internal carotid artery with greater than or equal to 80% as determined by angiography using NASCET methodology;
• Patients with reference vessel diameters 4.0 – 8.0 mm.
Sample Size 305 subjects that were treated in the pivotal IDE study G200007
Key Study Endpoints N/A
Follow-up Visits and Length of Follow-up To 3 years post-procedure
At 2-years and 3-years


Continued Follow-up Post-Approval Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 10/11/2025    
2 year report 10/11/2026    
3 year report 10/11/2027    
4 year report 10/10/2028    
5 year report 10/10/2029    


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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