CREATE Trial, Prospective, Observational Study

Study Overview
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Brief Summary
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Observation of the safety and effectiveness of Cre8 stents in patients with ischemic heart disease with long coronary lesions

Detailed Description
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The purpose of this study is to observe the prognosis of 200 patients with long lesions over 30 mm treated with a new-generation Cre8 stent that is polymer-free and releases fat-soluble ampilimus in the real world. In addition, in the case of inserting a 46mm very long stent through sub-analysis, we also want to check whether stent expansion is performed through OCT rather than IVUS.

Official Title
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Feasibility of CRE8 Polymer-free Amphilimus-eluting sTEnt in Patients With Diffuse Long Lesions (CREATE Trial): Prospective, Observational Study

Conditions
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Coronary Artery Disease, Drug Eluting Stent

Intervention / Treatment
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* Device: CRE8 polymer-free Amphilimus-eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 years of age or older Clinical evidence of coronary artery disease, including asymptomatic ischemia, stable angina, and acute coronary syndrome (unstable angina, non-ST-segment elevation myocardial infarction, ST-segment elevation myocardial infarction) Coronary artery lesion length 30 mm or more Those who voluntarily agreed in writing to participate in this clinical study Exclusion Criteria: Remaining life expectancy is less than 1 year Subjects with known hypersensitivity or contraindication to the following drugs or substances: heparin, aspirin, clopidogrel, prasugrel, ticagrelor In case the other researcher judges that it is inappropriate to participate in this study (pregnant women, the elderly, etc.)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CRE8 polymer-free Amphilimus-eluting stent|Percutaneous coronary intervention using a Cre8 stent for long lesions|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure including deaht, MI, ST, TLR | number of Target lesion failure including deaht, MI, ST, TLR | 12 months after the index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death | number of All cause death | 12 months after the index procedure | 
| Cardiac death | number of Cardiac death | 12 months after the index procedure | 
| Myocardial infarction | number of Myocardial infarction | 12 months after the index procedure | 
| Stent thrombosis : definite or probable stent thrombosis by ARC definition | number of Stent thrombosis | 12 months after the index procedure | 
| Target lesion revascularization | number of Target lesion revascularization | 12 months after the index procedure | 
| Target vessel revascularization | number of Target vessel revascularization | 12 months after the index procedure | 
| Stroke | number of Stroke | 12 months after the index procedure | 
| BARC bleeding 2-5 | number of BARC bleeding 2-5 | 12 months after the index procedure | 
| Stent overexpansion by OCT | Maximal stent diameter/ each diameter of stent | immediately after the index procedure in hospitalization |