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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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RESOLUTE ONYX CTO Post-approval study


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General
Study Status Progress Adequate
Application Number P160043 S012/ PAS001
Date Current Protocol Accepted  
Study Name RESOLUTE ONYX CTO Post-approval study
General Study Protocol Parameters
Study Design Meta Analysis
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Meta-analysis of CTO patients enrolled in on-going studies.



The objective of the RESOLUTE ONYX CTO Post-Approval Study (PAS) is to demonstrate the generalizability of the performance the Resolute family of drug-eluting stents for the treatment of chronic total occlusions (CTOs) in a real-world setting..

Study Population Description The RESOLUTE ONYX CTO PAS will consist of pooled lesion- and patient-level meta-analyses of subjects with CTOs treated with the Resolute Onyx stent system that are enrolled in the Primary, XLV and Bifurcation Cohorts of the RESOLUTE ONYX Post-Approval Study and the ONYX ONE outside of the US randomized controlled trial. Subjects will be followed according to the procedures in each respective study.
Sample Size Approximately 100 subjects between all three studies. No formal hypothesis will be conducted.
Data Collection The primary safety and effectiveness endpoint will be freedom from MACE (death, myocardial infarction, and clinically-driven target lesion revascularization) at 30-days. Secondary endpoints will include acute success (device, lesion, and procedure), cardiac death, target vessel MI, TLR, TLF, TVF, and stent thrombosis.
Follow-up Visits and Length of Follow-up 2 years


RESOLUTE ONYX CTO Post-approval study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 06/14/2019 06/13/2019 On Time
one year report 12/14/2019    
18 month report 06/13/2020    
two year report 12/13/2020    
three year report 12/13/2021    
four year report 12/13/2022    


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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