Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 960
- 试验地点
- 14
- 主要终点
- DoCE (Device-oriented Composite Endpoint)
研究概览
简要总结
Selution Iberia registry is a post-market clinical follow-up, prospective, multicenter, international, longitudinal, observational study without a control group of consecutive unselected "real-world" patients with coronary artery disease in whom it was decided to use the SELUTION SLRTM device in the treatment of primary native lesions and ISR (in-stent restenosis) in all settings, in order to evaluate its effectiveness and safety.
The primary objective is to evaluate the effectiveness and safety of the Sirolimus-eluting balloon SELUTION SLRTM based strategy in the treatment of native coronary artery stenosis and in-stent restenosis. The primary endpoint will be the incidence of major adverse cardiovascular events at 12 months, including death, non-fatal myocardial infarction or target lesion revascularization for ischemia, in an unselected "real-world" patient setting. Both Device Oriented Composite Endpoint (Cardiovascular death, device failure-related myocardial infarction or device failure-related ischaemia) and Patient Oriented Composite Endpoint (all cause death, any stroke, any myocardial infarction or any revascularization) will be detailed.
详细描述
Selution Iberia registry is a post-market clinical follow-up, prospective, multicenter, international, longitudinal, observational study without a control group of consecutive unselected "real-world" patients with coronary artery disease in whom it was decided to use the SELUTION SLRTM device in the treatment of primary native lesions and ISR in all settings, in order to evaluate its effectiveness and safety.
The primary objective is to evaluate the effectiveness and safety of the Sirolimus-eluting balloon SELUTION SLRTM based strategy in the treatment of native coronary artery stenosis and in-stent restenosis. The primary endpoint will be the incidence of major adverse cardiovascular events at 12 months, including death, non-fatal myocardial infarction or target lesion revascularization for ischemia, in an unselected "real-world" patient setting. Both Device Oriented Composite Endpoint (Cardiovascular death, device failure-related myocardial infarction or device failure-related ischaemia) and Patient Oriented Composite Endpoint (all cause death, any stroke, any myocardial infarction or any revascularization) will be detailed.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with age ≥18 years and;
- •Patients with coronary artery disease in whom, at the operator's discretion, treatment of a lesion in a native vessel, coronary graft or coronary restenosis is decided using the Selution SLRTM device;
- •Patient who has been informed of the characteristics of the study and has provided written informed consent.
排除标准
- •Express refusal of the patient to participate in the study
- •Life expectancy of the patient of less than 12 months
研究组 & 干预措施
Coronary Artery Disease (CAD)
干预措施: SELUTION SLRTM sirolimus coated balloon (Device)
结局指标
主要结局
DoCE (Device-oriented Composite Endpoint)
时间窗: 12 months
Incidence of DoCE, defined as Cardiovascular death, device failure-related MI (Myocardial Infarction) or device failure-related ischaemia)
PoCE (Patient-oriented Composite Endpoint)
时间窗: 12 months
Incidence of PoCE defined as all cause death, any stroke, any MI or any revascularization
MACE (Major Adverse Cardiovascular Events)
时间窗: 12 months
Incidence of MACE defined as death, nonfatal infarction, or need for TLR (Target Target Lesion Revascularization)
TLR
时间窗: 12 months
Number of Target Lesion Revascularizations
MACE (Major Adverse Cardiovascular Events)
时间窗: 12 months
Incidence of MACE defined as death, nonfatal infarction, or need for TLR (Target Target Lesion Revascularization)
TLR
时间窗: 12 months
Number of Target Lesion Revascularizations
DoCE (Device-oriented Composite Endpoint)
时间窗: 12 months
Incidence of DoCE, defined as Cardiovascular death, device failure-related MI (Myocardial Infarction) or device failure-related ischaemia)
PoCE (Patient-oriented Composite Endpoint)
时间窗: 12 months
Incidence of PoCE defined as all cause death, any stroke, any MI or any revascularization
次要结局
- MACE (Major Adverse Cardiovascular Events) in ISR(12 months)
- TLR in ISR(12 months)
- TLR in primary lesions in native vessel(12 months)
- TLR in bifurcation side branch lesions(12 months)
- MACE (Major Adverse Cardiovascular Events) in primary lesions in native vessel(12 months)
- MACE (Major Adverse Cardiovascular Events) in bifurcation side branch lesions(12 months)
- Procedure success(1 day)
- Death(12 months)
- Non fatal Myocardial Infarction(12 months)