Gangwon PCI Prospective Registry

Study Overview
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Brief Summary
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Comparison of Biolimus-eluting stent, Biomatrix, or Biomatrix Flex stent, Biosensors, Singapore Everolimus-eluting stent, Xience V, or Xience Prime, or Xience Xpedition stent, Abbott, USA Zotarolimus-eluting stent, Endeavor Resolute, or Endeavor Resolute Integrity stent Medtronic, USA in patients with coronary artery disease treated with percutaneous coronary intervention

Official Title
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Prospective Registry for Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention in Gangwon Province

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 19 years Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the drug-eluting stent(s) and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure Subject must have significant stenosis (>50% by visual estimate) on a native or in-stent coronary artery Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, acute myocardial infarction, positive functional study or a reversible changes in the ECG consistent with ischemia). In subjects with coronary artery stenosis >75%, evidence of myocardial ischemia does not have to be documented Exclusion Criteria: Subject has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, prasugrel, ticagrelor, biolimus A9, everolimus, zotarolimus, stainless steel, cobalt chromium, contrast media (Patients with documented sensitivity to contrast media, which can be effectively premedicated with steroid and diphenhydramine may be enrolled. However, those with true anaphylaxis to prior contrast media should not be enrolled.) Subject in use of systemic (intravenous) biolimus A9, everolimus or zotarolimus within 12 months. Female subject of childbearing potential, unless a recent pregnancy test is negative, who possibly plans to become pregnant any time after enrollment into this study Subject planned an elective surgical procedure that would necessitate interruption of antiplatelet during the first 12 months post enrollment Subject with non-cardiac co-morbid condition with life expectancy < 2 year or that may result in protocol non-compliance (per site investigator's medical judgment) Subject with cardiogenic shock at presentation Subject who are actively participating in another drug or device investigational study, who have not completed the primary end point follow-up period

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-oriented composite outcome | Device-oriented composite consisted of cardiac death, MI not clearly attributable to a nontarget vessel, and clinically indicated TLR at 24-month clinical follow-up | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-oriented composite outcome | Patient-oriented composite consisted of all-cause mortality, any MI, and any revascularization at 24-month clinical follow-up | 24 months | 
| Target vessel revascularization |  | 12 months | 
| Target vessel revascularization |  | 24 months | 
| ARC defined stent thrombosis |  | 12 months | 
| ARC defined stent thrombosis |  | 24 months |