Efficacy and Safety of ZotaRolimus-Eluting Coronary Stent System In Patients With Long Coronary Artery Disease

Study Overview
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Brief Summary
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This study is to evaluation the efficacy and safety of Zotarolimus-Eluting Stent in patients with long coronary artery disease of 25 mm or longer.

Detailed Description
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Study objectives: From this observational prospective study, the efficacy and safety of Zotarolimus-Eluting Stent in patients with coronary artery disease longer than 25mm is planned to be investigated. Background: Long coronary artery lesions are observed in 20% of all coronary interventions, and are associated with poor clinical outcomes. Zotarolimus-Eluting Stents are a new type of stent that combines the advantages of an Endeavour Resolute stent (drug eluting stent) and Integrity stent (bare metal stent). In other words, BioLinx polymer is used which is an advantage of Endeavour Resolute stent to secure clinical efficiency through stable drug release while ensuring flexibility and excellent deliverability, which is the advantage of Integrity stent. To date, there are only few studies to evaluate the efficacy and safety of Zotarolimus-Eluting Stent in the treatment of coronary artery disease. Therefore, the investigators planned to carry out a multicenter, prospective observational study to evaluated the efficacy and safety of Zotarolimus-Eluting Stent in patients with long coronary artery disease of 25 mm or longer.

Official Title
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Evaluation of Effectiveness and Safety of ZotaRolimus-Eluting Coronary Stent System In Patients With Long Coronary Artery Disease; A Multicenter, Prospective, Observational Registry Study

Conditions
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Coronary Artery Disease, Myocardial Ischemia, Coronary Disease

Intervention / Treatment
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* Device: Zotarolimus-Eluting Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 19 years old Evidence of myocardial ischemia and coronary artery diameter stenosis≥ 50% and lesion length ≥ 25mm At least 2.5 mm diameter coronary vessel by visual estimation Patients treated with Zotarolimus-eluting stent Exclusion Criteria: Previous coronary stent implantation Patients perticipated in other clinical trials of drugs or device Target vessel saphenous vein graft In-stent re-stenosis lesion Contraindicated to anti-platelet agents or hypersensitivity Past history of malignancy within 5 years History of anaphylaxis to contrast agent Pregnancy and lactation Life expectancy < 1-year End stage renal disease on dialysis

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

| Intervention/Treatment |
| --- |
|Device: Zotarolimus-Eluting Stent|Percutaneous coronary intervention using zotarolimus-eluting stent|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure | Composite endpoint of clinically driven target lesion revascularization, myocardial infarction or cardiac death related to target vessel | Index admission to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death | Cumulative incidence rate of all-cause death at each visit | Index admission, 1 month, 6 months, 12 months | 
| Cardiac death | Cumulative incidence rate of cardiac death at each visit | Index admission, 1 month, 6 months, 12 months | 
| Myocardial Infarction | Cumulative incidence rate of myocardial infarction at each visit | Index admission, 1 month, 6 months, 12 months | 
| All-cause death or Myocardial infarction | Cumulative incidence rate of all-cause death or myocardial infarction at each visit | Index admission, 1 month, 6 months, 12 months | 
| Cardiac death or Myocardial infarction | umulative incidence rate of cardiac death or myocardial infarction at each visit | Index admission, 1 month, 6 months, 12 months | 
| Target vessel revascularization | Cumulative incidence rate of target vessel revascularization at each visit | Index admission, 1 month, 6 months, 12 months | 
| Target lesion revascularization | Cumulative incidence rate of target lesion revascularization at each visit | Index admission, 1 month, 6 months, 12 months | 
| Stent thrombosis | Cumulative incidence rate of stent thrombosis at each visit | Index admission, 1 month, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Zotarolimus-Eluting Stent, Long Coronary Artery Disease, Target lesion failure