NCT05658250进行中（未招募）不适用
Feasibility of CRE8 Polymer-free Amphilimus-eluting sTEnt in Patients With Diffuse Long Lesions (CREATE Trial): Prospective, Observational Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Target lesion failure including deaht, MI, ST, TLR
研究概览
简要总结
Observation of the safety and effectiveness of Cre8 stent, Cre8 evo stent in patients with ischemic heart disease with long coronary lesions
详细描述
The purpose of this study is to observe the prognosis of 300 patients with long lesions over 30 mm treated with a new-generation Cre8 stent, Cre8 evo 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.)
结局指标
主要结局
Target lesion failure including deaht, MI, ST, TLR
时间窗: 12 months after the index procedure
number of Target lesion failure including deaht, MI, ST, TLR
次要结局
- All cause death(12 months after the index procedure)
- Cardiac death(12 months after the index procedure)
- Myocardial infarction(12 months after the index procedure)
- Target lesion revascularization(12 months after the index procedure)
- Stroke(12 months after the index procedure)
- Stent thrombosis : definite or probable stent thrombosis by ARC definition(12 months after the index procedure)
- Target vessel revascularization(12 months after the index procedure)
- BARC bleeding 2-5(12 months after the index procedure)
- Stent overexpansion by OCT(immediately after the index procedure in hospitalization)
研究者
研究点 (1)
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