RESOLUTE ONYX Post-Approval Study

Study Overview
=================
Brief Summary
-----------------
To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.

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

Conditions
-----------------
Coronary Artery Disease

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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 Key Exclusion Criteria Unprotected left main disease Subjects with planned PCI of three vessel disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Cohort<br>Subjects receiving stents 2.0 mm - 4.0 mm in diameter will be included in the Primary Cohort. | Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System<br>* Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm<br>|
| Extra Large Vessel (XLV) Cohort.<br>Subjects receiving stents 4.5 mm or 5.0 mm in diameter will be included in the Extra Large Vessel (XLV) Cohort. | Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System<br>* Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 4.5 mm - 5.0 mm<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Success (Device, Lesion, Procedure) | Acute Success (Device, Lesion, Procedure) | 30 days and 6, 12, 24, and 36 months post-procedure | 
| Cardiac Death | Cardiac Death | 30 days and 6, 12, 24, and 36 months post-procedure | 
| Target Vessel Myocardial Infarction (TVMI) | Target Vessel Myocardial Infarction (TVMI) | 30 days and 6, 12, 24, and 36 months post-procedure | 
| Target Lesion Revascularization (TLR) | Target Lesion Revascularization (TLR) | 30 days and 6, 12, 24, and 36 months post-procedure | 
| Target Vessel Revascularization (TVR) | Target Vessel Revascularization (TVR) | 30 days and 6, 12, 24, and 36 months post-procedure | 
| Cardiac Death and TVMI | Cardiac Death and TVMI | 30 days and 6, 12, 24, and 36 months post-procedure | 
| 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 | 30 days and 6, 12, 24, and 36 months post-procedure | 
| Target Lesion Failure (TLF) | Target Lesion Failure (TLF) | 30 days and 6, 12, 24, and 36 months post-procedure | 
| Target Vessel Failure (TVF) | Target Vessel Failure (TVF) | 30 days and 6, 12, 24, and 36 months post-procedure | 
| Stent Thrombosis (ST) | Stent Thrombosis (ST) | 30 days and 6, 12, 24, and 36 months post-procedure |