Effect and Efficacy of Xpedition™/Alpine™, Everolimus-eluting Stent for Coronary Atherosclerosis

Study Overview
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Brief Summary
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The objectives of this study are To establish a prospective registry of the whole patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™ stent To evaulate the long-term efficacy and safety of coronary stenting with the Xience Xpedition™/Alpine™ stent To compare the long-term efficacy and safety of coronary stenting between the Xience Xpedition™/Alpine ™ stent and other contemporary drug-eluting stents which had established their own registry

Detailed Description
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Secondary endpoints of this study are Stent thrombosis-24 hours(acute), 30 days(subacute), 1 year(late), every 1 year till 3 years(very-late) after index PCI Target vessl failure Composite rate of cardiac death and any MI, 3 years Composite rate of all death and any MI Composite rate of all death, any MI, and any repeat revascularization Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy

Official Title
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Harmonizing Optimal Strategy for Treatment of Coronary Atherosclerotic Lesions- Registry-based Study on the Effect and Safety of Xience Xpedition™/Alpine™, Everolimus-eluting Stent for Coronary Atherosclerotic Lesions: HOST-Alpine Registry

Conditions
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Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndrome, Angina Pectoris

Intervention / Treatment
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* Device: Alpine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient agrees to participate in this study by signing the informed consent form. Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form Exclusion Criteria: There are no exclusion criteria for this registry.

Ages Eligible for Study
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Minimum Age: 19 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alpine<br>The patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™ | Device: Alpine<br> <br> * Other names: Everolimus-eluting stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure | Composite of cardiac death, non-fatal target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target vessel failure | Composite of cardiac death, non-fatal target vessel related myocardial infarction, and ischemia-driven target vessel revascularization (TVR) | 12 months | 
| Composite rate of cardiac death and myocardial infarction |  | 12 months, 3 years | 
| Composite rate of all-cause death and any myocardial infarction |  | 12 months, 3 years | 
| Composite rate of all-cause death and any myocardial infarction, and any repeat revascularization |  | 12 months, 3 years | 
| Rate of compliance and interruptions with prescribed adjunctive antiplatelet therapy |  | 12 months, 3 years | 
| Clinical device and procedural success rate |  | intraoperative | 
| Stent thrombosis | acute (within 24 hours), subacute (1 - 30 days), late (31 days - 1 year), very late (>1 year) | within 24 hours, 1 - 30 days, 31 days - 1 year, after 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, percutaneous coronary intervention, everolimus-eluting stents