The Medtronic RESOLUTE US Clinical Trial

Study Overview
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Brief Summary
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The objective of the study is to assess the safety and effectiveness of the Resolute Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm.

Detailed Description
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The trial is comprised of four studies: the 2.25 mm - 3.5 mm main study (1242 patients), the 2.25 mm - 3.5 mm Angio/IVUS sub-study (100 patients), the 4.0 mm sub-study (60 patients), and the 38 mm Length Sub-study (114 patients). A patient's inclusion in a given study is dependent on the size (diameter or length) of the stent(s) the patient receives.

Official Title
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A Clinical Evaluation of the Medtronic Resolute Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries With a Reference Vessel Diameter of 2.25 mm to 4.2mm

Conditions
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Coronary Artery Disease

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


Participation Criteria
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Eligibility Criteria
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General and Angiographic Inclusion Criteria highlights: Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study Informed consent Patient agrees to comply with specified follow-up evaluations at same investigational site Single target lesion or two target lesions located in separate coronary arteries De novo lesion(s) in native coronary artery(ies) Target lesion(s) ≤ 27 mm in length (or ≤ 35 mm for a lesion to be treated with a 38 mm length stent) Target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm, (or 3.0 to 4.2 mm for it to be treated with a 38 mm length stent) General and Angiographic Exclusion Criteria highlights: Within 7 days of implant platelet count <100,000 cells/mm³ or >700,000 cells/mm³; WBC count <3,000 cells/mm³; serum creatinine level >2.5 mg/dl Acute MI within 72 hrs of the index procedure (QWMI or any elevation of CK-MB > lab upper limit of normal) Previous PCI of target vessel(s) within 9 months prior to the procedure Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure History of stroke or TIA within prior 6 months Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints Inability to comply with required trial antiplatelet regimen Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent Target vessel(s) has/have other lesions w/ > 40% diameter stenosis Unprotected left main coronary artery disease

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 |
| --- | --- |
| Experimental: Resolute Zotarolimus-Eluting Coronary Stent<br>Implantation of a Resolute Zotarolimus-Eluting Coronary Stent | Device: Resolute Zotarolimus-Eluting Coronary Stent<br>* Implantation of a Resolute Zotarolimus-Eluting Coronary Stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure (TLF) | Target Lesion Failure (TLF) at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (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 |
| --- | --- | --- |
| Target Vessel Failure (TVF) | Target Vessel Failure (TVF) composite endpoint and each individual component (Cardiac Death, Target Vessel MI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods). | 12 months | 
| Major Adverse Cardiac Event (MACE) | Major Adverse Cardiac Event (MACE) composite endpoint and each individual component (death, Target Vessel MI (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat Target Lesion Revascularization (TLR) by percutaneous or surgical methods). | 12 months | 
| Death |  | 12 months | 
| Target Vessel MI | Target Vessel MI (as determined by extended historical and ARC definitions). | 12 months | 
| Stent Thrombosis (ST) | Stent Thrombosis (ST) (as determined by historic and ARC definitions). | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TARGET VESSEL REVASCULARIZATION (TVR), MYOCARDIAL INFARCTION (MI), TARGET VESSEL FAILURE (TVF), TARGET LESION REVASCULARIZATION (TLR), TARGET LESION FAILURE (TLF), STENT THROMBOSIS, RESTENOTIC LESION, PERCUTANEOUS CORONARY INTERVENTION (PCI)