Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents (COASTLINE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,757
- 试验地点
- 2
- 主要终点
- Target vessel failure (TVF) at 1-year follow up in complex all-comers
研究概览
简要总结
Drug eluting stents (DES) are widely used for treatment of coronary artery lesions. The Xience Sierra stent has a refined design of the metal stent backbone and is used in patients with various clinical syndromes and in different lesions. Clinical outcome of patients with previously unknown (silent) diabetes and prediabetes is of increasing interest since the latter group has recently shown to be associated with a significant risk of adverse cardiovascular events after treatment with contemporary DES. Outcome data in a population of high-risk all-comer patients, including many patients with diabetes mellitus and prediabetes, would be of great interest, but such data are not available yet. In addition, there is a lack of data in a general all-comer population. Therefore, the COASTLINE study will primarily assess the safety and efficacy of the Xience Sierra stent in a general all-comer population as well as a high-risk all-comer population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years
- •requiring PCI and treated with Xience Sierra
- •capable of providing informed consent
排除标准
- •known intolerance to components of the study DES or antithrombotic/anticoagulant therapy
- •planned elective surgery necessitating interruption of dual antiplatelet therapy (DAPT) < 3 months
- •patient is known to be pregnant, unlikely to adhere to follow-up or expected live < 1 year
研究组 & 干预措施
All-comer patients requiring PCI
All-comer patients requiring percutaneous coronary intervention (PCI) for the treatment of significant coronary artery of bypass graft lesions that are suitable for treatment with Xience Sierra DES
干预措施: Percutaneous coronary intervention (Device)
结局指标
主要结局
Target vessel failure (TVF) at 1-year follow up in complex all-comers
时间窗: 1 year
TVF is a composite endpoint consisting of cardiac death, target vessel related myocardial infarction, or clinically driven target vessel revascularization.
Target lesion failure (TLF) at 2-year follow up in all-comers
时间窗: 2 year
TLF is a composite endpoint consisting of cardiac death, target vessel related myocardial infarction, or clinically driven target lesion revascularization.
次要结局
- Clinically indicated target vessel revascularization(up to 3 year)
- TVF at 2 year follow up(2 year)
- Death(up to 3 year)
- Myocardial infarction(up to 3 year)
- Clinically indicated target lesion revascularization(up to 3 year)