Medtronic Resolute Onyx 2.0 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 that allows the use of a 2.0 mm diameter stent.

Official Title
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A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent Resolute Onyx 2.0 mm Clinical Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Resolute Onyx Stent - 2.0 mm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be an acceptable candidate for percutaneous coronary intervention, stenting, & emergent coronary artery bypass graft (CABG) surgery Must have evidence of ischemic heart disease Must require treatment of either a) a single target lesion amenable to treatment with a 2.0 mm stent OR b) two target lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.0 mm study stent 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 Coronary Stent System 2.0 mm Stent | Device: Resolute Onyx Stent - 2.0 mm<br>* Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Target Lesion Failure at 12 Months Post-Procedure | Target Lesion Failure at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (Q wave or non-Q wave) or Target Lesion Revascularization by percutaneous or surgical methods. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Cardiac Death at 12 Months Post Procedure |  | 12 Months | 
| Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 12 Months Post Procedure | TVMI defined as Q Wave or non-Q Wave MI | 12 Months | 
| Number of Participants With a Major Adverse Cardiac Event at 12 Months Post Procedure |  | 12Months | 
| Number of Participants With Target Lesion Failure (TLF) at 24 Months Post Procedure |  | 24 Months | 
| Number of Participants With Target Vessel Failure (TVF) at 12 Months Post Procedure |  | 12 Months | 
| Number of Participants With Stent Thrombosis (ST) at 12 Months Post Procedure |  | 12 Months | 
| Number of Participants With Cardiac Death at 24 Months Post Procedure |  | 24 Months | 
| Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 24 Months Post Procedure | TVMI defined as Q Wave or non-Q Wave MI | 24 Months | 
| Number of Participants With a Major Adverse Cardiac Event at 24 Months Post Procedure |  | 24 Months | 
| Number of Participants With Target Vessel Failure (TVF) at 24 Months Post Procedure |  | 24 Months | 
| Number of Participants With Stent Thrombosis (ST) at 24 Months Post Procedure |  | 24 Months | 
| Number of Participants With Target Lesion Failure (TLF) at 36 Months Post Procedure |  | 36 Months | 
| Number of Participants With Cardiac Death at 36 Months Post Procedure |  | 36 Months | 
| Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 36 Months Post Procedure | TVMI defined as Q Wave or non-Q Wave MI | 36 Months | 
| Number of Participants With a Major Adverse Cardiac Event at 36 Months Post Procedure |  | 36 Months | 
| Number of Participants With Target Vessel Failure (TVF) at 36 Months Post Procedure |  | 36 Months | 
| Number of Participants With Stent Thrombosis (ST) at 36 Months Post Procedure |  | 36 Months |