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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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ODE Lead-Cont f/u RESOLUTE ONYX Clinical


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General
Study Status Study Pending
Application Number P160043 / PAS001
Study Name ODE Lead-Cont f/u RESOLUTE ONYX Clinical
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 Continued Follow-up of premarket cohort (Core 2.25mm-4.00mm Clinical Study)
Study Population Description Single arm study with Resolute Onyx Stent System
Sample Size 75 subjects (already enrolled)
Data Collection The primary safety and effectiveness endpoints is late lumen loss at 8 month post-index procedure. Unpowered secondary endpoints include acute success (device, lesion and procedure), cardiac death, target vessel MI, target lesion revascularization, MACE, target lesion failure, target vessel failure and stent thrombosis.
Follow-up Visits and Length of Follow-up 3 years


ODE Lead-Cont f/u RESOLUTE ONYX Clinical Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 04/28/2018    
two year report 04/28/2019    
three year report 04/27/2020    
four year report 04/27/2021    
five year report 04/27/2022    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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