Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study

Study Overview
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Brief Summary
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The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter of 2.25 mm to 4.2 mm.

Official Title
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A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting Stent System Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Resolute Onyx Stent - 2.25 mm - 4.0 mm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be an acceptable candidate for percutaneous coronary intervention (PCI), stenting, and emergent coronary artery bypass graft (CABG) surgery Must have clinical evidence of ischemic heart disease, stable or unstable angina, and/or a positive functional study Must require treatment of either a) a single target lesion amenable to treatment OR b) two target lesions located in separate target vessels Target lesion(s) must be de novo lesion(s) in native coronary artery(ies) Exclusion Criteria: Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative History of a stroke or transient ischemic attack (TIA) within the prior 6 months Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months History of bleeding diathesis or coagulopathy or will refuse blood transfusions Concurrent medical condition with a life expectancy of less than 12 months Currently participating in an investigational drug or another device trial that has not completed the primary endpoint Documented left ventricular ejection fraction (LVEF) < 30% at the most recent evaluation

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Device<br>Medtronic Resolute Onyx Zotarolimus-Eluting Stent System | Device: Resolute Onyx Stent - 2.25 mm - 4.0 mm<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography | In-stent late lumen loss at 8-months post-procedure as measured by quantitative coronary angiography | 8 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Death |  | 8 Months | 
| Target Vessel Myocardial Infarction (TVMI) |  | 8 Months | 
| Target Lesion Revascularization (TLR) |  | 8 Months | 
| 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 | 8 Months | 
| Target Lesion Failure (TLF) |  | 8 Months | 
| Target Vessel Failure (TVF) |  | 8 Months | 
| Stent Thrombosis (ST) |  | 8 Months | 
| Cardiac Death and TVMI |  | 8 Months |