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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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RESOLUTE ONYX PAS


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General
Study Status Completed
Application Number /
Requirement Number		 P160043 / PAS002
Study Name RESOLUTE ONYX PAS
Device Name RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives RESOLUTE ONYX Post-Approval Study
Study Population Single arm study with Resolute Onyx Stent System
Sample Size 510 (up to 50 subjects may be enrolled prior to PMA approval)
Key Study Endpoints The primary endpoint is incidence of Target Lesion Failure (TLF) at 12 months, defined as Cardiac Death, Target Vessel MI or Target Lesion Resvascularization.
Follow-up Visits and Length of Follow-up 36 months
Interim or Final Data Summary
Interim Results At 12 months (XLV cohort ITT Population): Target lesion Failure (TLF) was 10.9 (11/101) with 2- sided 95% CI of [5.6%, 18.7%]
At 24 months (XLV cohort ITT Population): Major Adverse Cardiac Event was 21.8% (22/101),
Cardiac death was 4.0% (4/101), clinically driven TVR 9.9% (10/101), clinically driven TLR was 8.9% (9/101), TLF 16.8% (17/101), target vessel failure 17.8% (18/101) and ARC definite Stent thrombosis 1.0% (1/101).
Actual Number of Patients Enrolled 101 subjects
Actual Number of Sites Enrolled 17 - (14 US, 3 EU)
Patient Follow-up Rate The rate of TLF in the XLV Cohort ITT population at 12 months was 10.9% (11/101), with two-sided 95% CI of [5.6%, 18.7%]. At 24-months, cardiac death rate was reported as 4.0% (4/101), TVMI (3rd UDMI) as 8.9% (9/101), clinically driven TLR 9.9% (10/101), clinically driven TVR 10.9% (11/101), TLF 17.8% (18/101) and TVF 18.8% (19/101). There was one ARC definite ST [1.0% (1/101)]. At 36-months, cardiac death rate was reported as 5.1% (5/99), TVMI (3rd UDMI) as 10.1% (10/99), clinically driven TLR
Final Safety Findings The 12-month primary endpoint results of the RESOLUTE ONYX PAS XLV Cohort demonstrated the safety and effectiveness of Resolute Onyx for the treatment of lesions in coronary arteries amenable to treatment with a Resolute Onyx 4.5 mm – 5.0 mm stent. Results from the 24-month and 36-month data continue to support the safety and effectiveness of this device for stent sizes 4.5 mm and 5.0 mm in treating complex coronary lesions.
Recommendations for Labeling Changes Yes


RESOLUTE ONYX PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 04/28/2018 04/26/2018 On Time
18 month report 10/28/2018 10/16/2018 On Time
2 year report 08/15/2019 08/14/2019 On Time
3 year report 04/27/2020 04/24/2020 On Time
4 year report 04/27/2021 04/23/2021 On Time
5 year report 04/27/2022 03/22/2022 On Time
final report 04/27/2023 03/30/2023 On Time


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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