An Evaluation of the Commercially Available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System

Study Overview
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Brief Summary
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The purpose of this post approval study is to conduct a prospective, multicenter evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System.

Detailed Description
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The purpose and objective is to assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter(RD) of 2.25mm to 4.2mm in two groups of patients, specifically those patients receiving stents less than or equal to 30mm in length.

Official Title
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Resolute Integrity US A Postapproval Study of the Medtronic Resolute™ Integrity 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 4.2 mm

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Resolute Integrity 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 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 Target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm General and Angiographic Exclusion Criteria highlights: Within 7 days of index procedure platelet count <100,000 cells/mm³ or >700,000 cells/mm³; White Blood Cell (WBC) count <3,000 cells/mm³; serum creatinine level >2.5 mg/dl Acute MI within 72 hrs of the intended trial procedure (QWMI or any elevation of Creatine Kinase-MB (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 Transient Ischemic Attack (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 |
| --- | --- |
| Other: Resolute Integrity<br>Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity Stent) | Device: Resolute Integrity Stent<br>* Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI |  | 12 months | 
| Clinical Endpoint: Death |  | 12 months | 
| Dual Antiplatelet Therapy (DAPT) Compliance |  | 12 months | 
| Clinical Endpoint: TLR |  | 12 months | 
| Clinical Endpoint: TVR |  | 12 months | 
| Clinical Endpoint: MI |  | 12 months | 
| Clinical Endpoint: ST |  | 12 months | 
| Clinical Endpoint: Stroke |  | 12 months | 
| Clinical Endpoint: Bleeding Complications in General |  | 12 months | 

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