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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 CTO Post-approval study

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Study Status Completed
Application Number /
Requirement Number
P160043 S012/ PAS001
Date Original Protocol Accepted 03/08/2019
Date Current Protocol Accepted  
Study Name RESOLUTE ONYX CTO Post-approval study
Device Name Resolute Onyx Zotarolimus-Eluting Coronary Stent System
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 Objectives 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 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.
Key Study Endpoints 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
Interim or Final Data Summary
Actual Number of Patients Enrolled 78
Actual Number of Sites Enrolled 28
Patient Follow-up Rate 92.3% (72/78)
Final Safety Findings Target lesion revascularization (TLR) rate and contributing to an overall 33.3% (10/30) TLF, TVF, and MACE rate. Lesion success defined as attainment of <50% residual stenosis of the target lesion using any percutaneous method was 100% (47/47) and device success defined as attainment of <50% residual stenosis of the target lesion using only Resolute Onyx was reported at 97.9% (46/47). Procedure success defined as attainment of <50% residual stenosis of the target lesion and no in-hospital MACE was reported at 70.0% (21/30) where failures were solely driven by the nine (9) peri-procedural ARC MIs reported for this cohort.

Final Effect Findings The study used a primary composite endpoint of Freedom from Major Adverse Cardiac Events (MACE) defined as any death, myocardial infarction (per
ARC definition), or clinically-driven target lesion revascularization (TLR) at 30-days was established as the primary endpoint for these cohorts. In total the MACE rate was 79.5% (62/78).
Primary Endpoint Onyx PAS CTO (N=30 subjects) Onyx ONE CTO (N=35 Subjects) Onyx ONE Clear CTO (N=13 Subjects)
Freedom from MACE at 30 days 70.0% 88.6% 76.9%
The freedom from MACE rate is a cumulative probability of event-free estimate based on the Kaplan-Meier Method.
MACE (death, myocardial infarction (per ARC MI definition), and clinically-driven target lesion revascularization)
Study Strengths & Weaknesses The strength of this study is that I captures a close approximation of a real world population. The data included a large number of investigators at multiple sites providing a wide range of patients. This data helps to reflect how the device will perform in the clinical community. However, this trial was a single arm investigation which is a limitation. While this is not noted as a major weakness of the trial, it should be noted as a limitation.
Recommendations for Labeling Changes We have recommended that the sponsor submit a labeling amendment to include this information in their future DFU.

RESOLUTE ONYX CTO Post-approval study Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 06/14/2019 06/13/2019 On Time
one year report 12/14/2019 12/12/2019 On Time
18 month report 06/13/2020 06/11/2020 On Time
two year report 12/13/2020 12/09/2020 On Time
final report 12/13/2022 01/13/2022 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

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