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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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SCAFFOLD Continued f/u study


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General
Study Status Study Pending
Application Number P180010 / PAS001
Study Name SCAFFOLD Continued f/u study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Multicenter, single-arm, prospective study comparing the

GORE® Carotid Stent to a performance goal developed

from carotid endarterectomy (CEA) outcomes

Study Population Description Continued follow-up of IDE cohort
Sample Size 290 remaining IDE subjects, active at the end of the 1-year evaluation
Data Collection 1-year MAE rate compared to PG
Follow-up Visits and Length of Follow-up 3 years post-procedure


SCAFFOLD Continued f/u study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 11/01/2019   Overdue
two year report 10/31/2020    
three year report 10/31/2021    
four year report 10/31/2022    


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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