RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)

Study Overview
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Brief Summary
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To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population. To collect data on the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in bifurcated lesions.

Official Title
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A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria Symptomatic coronary artery disease including subjects with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation and ST-elevation myocardial infarction Subject is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use, and the Declaration of Helsinki Subject requires treatment of a single de novo bifurcated lesion amenable to treatment with Resolute Onyx using the provisional stenting technique Exclusion Criteria: Unprotected left main disease Subjects with planned PCI of three vessel disease Planned two stent technique (main branch and side branch) of a bifurcation Subjects with more than one bifurcation lesion

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Bifurcation Cohort<br>Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. | Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System<br>* Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 5.0 mm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Cardiac Death | Cardiac Death defined as any death due to immediate cardiac cause, unwitnessed death and death of unknown cause. | 12 months | 
| Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI) | Target Vessel Myocardial Infarction (TVMI) defined as myocardial infarction with the target vessel. (3rd UDMI) | Up to 12 months | 
| Number of Participants With Target Lesion Revascularization (TLR) | Target Lesion Revascularization (TLR) defined as repeat PCI (Percutaneous Coronary Intervention), CABG (Coronary Artery Bypass Surgery) to the target lesion, or clinically driven target lesion revascularization. | 12 months | 
| Number of Participants With Target Vessel Revascularization (TVR) | Target Vessel Revascularization (TVR) defined as revascularization of the target vessel. | 12 months | 
| Number of Participants With Cardiac Death and TVMI | Cardiac Death and TVMI defined as composite of cardiac death and target vessel myocardial infarction. | 12 months | 
| Number of Participants With Major Adverse Cardiac Event (MACE) | Major Adverse Cardiac Event (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically driven repeat target lesion revascularization by percutaneous or surgical methods. | 12 months | 
| Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure (TLF) defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods. | 12 months | 
| Number of Participants With Stent Thrombosis (ARC) Definite/Probable | Stent Thrombosis Definite/Probable defined per Academic Research Consortium (ARC). Definite: a. Angiographic confirmation of TIMI flow grade 0-3 and at least one of the following criteria within a 48 hour: 1.New onset s ischemic symptoms at rest (typical chest pain with duration >20 minutes); 2.New ischemic ECG changes suggestive of acute ischemia; 3.Typical rise and fall in cardiac biomarkers. or b. Pathologic confirmation of stent thrombosis: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable: Any unexplained death within the first 30 days. | 12 months |