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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P110013 S088/ PAS001 |
| Date Original Protocol Accepted |
03/08/2019
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| Date Current Protocol Accepted |
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| Study Name |
RESOLUTE ONYX CTO Post-approval study
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| Device Name |
Resolute Integrity Zotarolimus-Eluting Coronary Stent System
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| General Study Protocol Parameters |
| Study Design |
Meta Analysis
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| Data Source |
Sponsor Registry
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| Comparison Group |
Device Subjects Serve as Own Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Meta-analyis 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..
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| 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.
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| Sample Size |
Approximately 100 subjects between all three studies. No formal hypothesis will be conducted.
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| 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.
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| Follow-up Visits and Length of Follow-up |
2 years
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
78
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| Actual Number of Sites Enrolled |
28
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| Patient Follow-up Rate |
92.3% (72/78)
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| 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.
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| 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)
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| 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.
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| Recommendations for Labeling Changes |
We have recommended that the sponsor submit a labeling amendment to include this information in their future DFU.
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