Coronary Angioplasty With Sirolimus Drug-coated Stent System to Treat Patients With Symptomatic Ischemic Coronary Heart Disease: a PMCF Study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- OrbusNeich
- 入组人数
- 251
- 试验地点
- 10
- 主要终点
- Adjudicated, device-oriented, Target Lesion Failure (TLF)
研究概览
简要总结
To collect post marketing surveillance data on consecutive patients with coronary heart disease intended to be or treated by the Eucalimus sirolimus eluting PTCA stent when used according to the Instructions for Use. Data will be collected in order to assess the long term safety and performance of the Eucalimus PTCA stent in routine clinical practice.
详细描述
The multicenter, prospective registry population consists of consecutive patients with coronary heart disease who undergo percutaneous coronary intervention (PCI) and are intended to be or treated by the Eucalimus sirolimus eluting PTCA stent (according to the Instructions for Use) as part of routine clinical care. Approximately 251 patients from 5-10 centers in Europe and Asia will be entered into the registry. Patients entered into the registry are followed for three years. The registry is considered finished when all patients have completed the 36-month follow-up.
A follow-up is scheduled at the following timepoints: immediately post-procedure, 30 days, 6 months, 12 months, 24 months, and 36 months. Follow-up is obtained by telephone contact with the patient or at a planned hospital visit.
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
- •Consecutive patients intended to be, or treated by EucaLimus as per physicians' decision and according to Instructions for Use (IFU) in the setting of routine clinical care are entered into the registry.
排除标准
- •Patients are excluded from registration if ANY of the following conditions apply:
- •High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- •Currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned
- •A life expectancy of <1year
- •Explicit refusal of participation in the registry
研究组 & 干预措施
Device: EucaLimus coronary stent system
The EucaLimus coronary stent system is a drug-coated coronary stent system, indicated for use in patients with symptomatic ischaemic coronary heart disease due to de novo lesions or restenosed lesions of the coronary arteries.
干预措施: EucaLimus coronary stent system (Device)
结局指标
主要结局
Adjudicated, device-oriented, Target Lesion Failure (TLF)
时间窗: 12 months post procedure
Adjudicated, device-oriented, Target Lesion Failure (TLF) where TLF is defined (Academic Research Consortium- ARC) as a composite of cardiac death (CD), non-fatal myocardial infarction (MI) not clearly attributable to a non-target vessel (TV-MI) or clinically driven target lesion revascularization (cd-TLR).
次要结局
- Adjudicated Target Lesion Failure (TLF)(through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months)
- Each of the components of TLF (Cardiac Death (CD), non-fatal myocardial infarction not clearly attributable to a non-target vessel (TV-MI), clinically driven target lesion revascularization (cd-TLR))(through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months)
- Adjudicated Target Vessel Failure (TVF) (ARC definition) as a composite of Cardiovascular Death (CVD), TV-MI and clinically driven target vessel revascularization (cd-TVR)(through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months)
- Each of the components of TVF (Cardiovascular Death (CVD), TV-MI and clinically driven target vessel revascularization (cd-TVR))(through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months)
- Adjudicated stent thrombosis per ARC-2 definition(through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months)
- Adjudicated bleeding Type 3-5 per the Bleeding Academic Research Consortium (BARC) definition(through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months)
- Adjudicated stroke(through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months)
- Device success(Index Procedure)
- Procedure Success(Index Procedure)