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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 Study


General
Study Status Study Pending
Application Number /
Requirement Number		 P240029 / PAS001
Date Original Protocol Accepted 06/23/2025
Date Current Protocol Accepted 06/23/2025
Study Name Continued Follow-up Study
Device Name CGuard Prime Carotid Stent System
Clinical Trial Number(s) NCT04900844 
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 This study is a prospective, multicenter follow-up of the pivotal study (G190185) that treated 316 subjects from 24 investigational sites. It will evaluate the long-term safety and effectiveness of the CGuard Prime Carotid Stent System. All 303 remaining subjects active at the end of the 12-month evaluation will continue to be followed annually through 36 months.
Study Population The study has 303 remaining subjects who will follow-up at 24- and 36-Month time points.
Sample Size 303 subjects
Key Study Endpoints The following assessments are performed:
· Anticoagulant and/or antiplatelet medications (concomitant medications)
· Targeted physical exam (can be performed by licensed personnel)
· NIH Stroke Scale
· Modified Rankin Scale
· Carotid Duplex Ultrasound
· INR for subjects on long term VKA anticoagulant therapy
· Adverse Event Assessment
Follow-up Visits and Length of Follow-up 36 months


Continued Follow-up Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 06/23/2026    
2 year report 06/23/2027    
3 year report 06/22/2028    
4 year report 06/22/2029    
5 year report 06/22/2030    


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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