Effect and Efficacy of Onyx™, Zotarolimus-eluting Stent for Coronary Atherosclerosis

Study Overview
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Brief Summary
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The objectives of this study are To establish a prospective registry of the whole patients who received percutaneous coronary intervention with Resolute Onyx™ stent. To evaluate the long-term efficacy and safety of coronary stenting with the Resolute Onyx™ stent. To compare the long-term efficacy and safety of coronary stenting between the Resolute Onyx™ stent and other contemporary drug-eluting stents which had established their own registry.

Detailed Description
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Secondary endpoints are Stent thrombosis-24 hours(acute), 30 days(subacute), 1 year(late), every 1 year till 3 years(very-late) after index PCI (percutaneous coronary intervention), Target vessel failure Composite rate of cardiac death and any MI, 3 years Composite rate of all death and any MI Composite rate of all death, any MI, and any repeat revascularization Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy Clinical device and procedural success

Official Title
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Harmonizing Optimal Strategy for Treatment of Coronary Atherosclerotic Lesions - Registry-based Study on the Effect and Safety of Onyx™, Zotarolimus-eluting Stent for Coronary Atherosclerotic Lesions: HOST-Onyx Registry

Conditions
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Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction, Angina Pectoris

Intervention / Treatment
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* Device: Resolute Onyx


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age above 19 Patients who received PCI with Resolute Onyx™ stent(s) Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Onyx<br>The patients who received PCI with Resolute Onyx stent(s) | Device: Resolute Onyx<br> <br> * Other names: Zotarolimus-eluting stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure | Composite of cardiac death, non-fatal target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent thrombosis, acute | according to Academic Research Consortium (ARC) definition | within 24 hours after index PCI | 
| Stent thrombosis, subacute | according to ARC definition | from 24 hours to 30 days after index PCI | 
| Stent thrombosis, late | according to ARC definition | from 30 days to 1 year after index PCI | 
| Stent thrombosis, very-late | according to ARC definition | 1 year   up to 3 years | 
| Target vessel failure | Composite of cardiac death, non-fatal target vessel related myocardial infarction, and ischemia-driven target vessel revascularization (TVR) | 12 months | 
| Composite rate of cardiac death and myocardial infarction | as title | 12 months, 3 years | 
| Composite rate of all-cause death and any myocardial infarction | as title | 12 months, 3 years | 
| Composite rate of all-cause death and any myocardial infarction, and any repeat revascularization | as title | 12 months, 3 years | 
| Rate of compliance and interruptions with prescribed adjunctive antiplatelet therapy | we will estimate this outcome with relevant questionnaire | 12 months, 3 years | 
| Clinical device and procedural success rate | device success : residual stenosis <30%, final thrombolysis in myocardial infarction (TIMI) flow grade III procedural success : device success + no adverse events immediate after the procedure | intraoperative ( index PCI) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, percutaneous coronary intervention, zotarolimus-eluting stents