Resolute Integrity US Extended Length Sub-Study(RI US XL)

Study Overview
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Brief Summary
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Prospective, multi-center, non-randomized, single-arm, open-label study 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 (RVD) of 2.25 mm to 4.2 mm in patients who receive extended length stents (34 mm or 38 mm) referred to as the Extended Length Study.

Detailed Description
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The purpose of this postapproval study is to conduct a prospective, multi-center evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available 34 mm and 38 mm Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System. Descriptive statistics and 95% confidence intervals will be calculated for clinically relevant variables as described in a separate statistical analysis plan.

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) ≤ 35 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 Myocardial Infarction (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>Resolute Integrity Stent | Device: Resolute Integrity Stent<br>* Drug eluting stent (DES)<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) | The combined clinical outcome of (all cause) mortality, MI or any revascularization | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Endpoint: Major Adverse Cardiac Events (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, 6 months, 12 months | 
| Composite Endpoint: 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 | 30 days, 6 months, 12 months | 
| Composite Endpoint: Target Vessel Failure (TVF), | The composite endpoint comprised of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods. | 30 days, 6 months, 12 months | 
| Composite Endpoint: Cardiac Death and Target Vessel MI | Combined rate of cardiac death and target vessel MI post-procedure | 30 days, 6 months, 12 months | 
| Composite Endpoint: Target Vessel MI | Target-vessel MI is defined as a MI that occurs in a territory that cannot be clearly attributed to a vessel other than the target vessel. | 30 days, 6 months, 12 months | 
| Clinical Endpoint: Death | All deaths including cardiac death, vasular death and non-cardiovascular death | 30 days, 6 months, 12 months | 
| Clinical Endpoint: Myocardial Infarction (MI) | All myocardial infarction data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions. | 30 days, 6 months, 12 months | 
| Clinical Endpoint: Target Lesion Revascularization (TLR) | Repeat Percutaneous coronary intervention (PCI) or Coronary artery bypass grafting (CABG) to the target lesion. | 30 days, 6 months, 12 months | 
| Clinical Endpoint: Target Vessel Revascularization (TVR) | Repeat PCI or CABG of the target vessel. | 30 days, 6 months, 12 months | 
| Clinical Endpoint: Stent Thrombosis | All stent thrombosis data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions | Early Thrombosis (<=30 days), Late Thrombosis (31-360 days) | 
| Clinical Endpoint: Stroke | Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours. | 30 days, 6 months, 12 months | 
| Clinical Endpoint: Bleeding Complications in General | Bleeding complications in general including the GUSTO classification of Severe, Moderate & Mild will be collected. The GUSTO scale defines clinical events that stratify bleeding episodes into mild, moderate or severe. | 30 days, 6 months, 12 months | 
| Dual Antiplatelet Therapy (DAPT) Compliance | Protocol defined DAPT, Aspirin and Clopidogrel or Ticlopidine, at 30 days, 180 day and 360 days. | 30 days, 6 months, 12 months | 

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