NCT03151018Unknown不适用
Harmonizing Optimal Strategy for Treatment of Coronary Atherosclerotic Lesions - Registry-based Study on the Effect and Safety of Onyx™, Zotarolimus-eluting Stent for Coronary Atherosclerotic Lesions: HOST-Onyx Registry
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 4,000
- 试验地点
- 16
- 主要终点
- Target lesion failure
研究概览
简要总结
The objectives of this study are
- To establish a prospective registry of the whole patients who received percutaneous coronary intervention with Resolute Onyx™ stent.
- To evaluate the long-term efficacy and safety of coronary stenting with the Resolute Onyx™ stent.
- To compare the long-term efficacy and safety of coronary stenting between the Resolute Onyx™ stent and other contemporary drug-eluting stents which had established their own registry.
详细描述
Secondary endpoints are
- Stent thrombosis-24 hours(acute), 30 days(subacute), 1 year(late), every 1 year till 3 years(very-late) after index PCI (percutaneous coronary intervention),
- Target vessel 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
- Clinical device and procedural success
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 19
- •Patients who received PCI with Resolute Onyx™ stent(s)
排除标准
- 未提供
结局指标
主要结局
Target lesion failure
时间窗: 12 months
Composite of cardiac death, non-fatal target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)
次要结局
- Stent thrombosis, very-late(1 year ~ up to 3 years)
- Clinical device and procedural success rate(intraoperative ( index PCI))
- Stent thrombosis, acute(within 24 hours after index PCI)
- Target vessel failure(12 months)
- Stent thrombosis, subacute(from 24 hours to 30 days after index PCI)
- Stent thrombosis, late(from 30 days to 1 year after index PCI)
- 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)
研究者
Hyo-Soo Kim
Professor
Seoul National University Hospital
研究点 (16)
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