Safety Assessment of Angioplasty Procedures
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 984
- 试验地点
- 1
- 主要终点
- Number of Major Adverse Cardiac Events (MACE)
研究概览
简要总结
Ischemic heart disease, or coronary heart disease, covers a set of pathologies due to insufficient oxygen supply to the myocardium due to the development of atherosclerosis in one or more coronary arteries. To evaluate the safety of angioplasty performed in patients operated on at La Rochelle Hospital, the rate of major adverse cardiac events (MACE) will be determined and compared with data from the literature.
详细描述
The use of active stents for the treatment of coronary stenosis is currently the standard treatment in almost all types of coronary lesions. In percutaneous transluminal treatment of coronary lesions, balloon angioplasty and bare stents have not shown satisfactory results in the past. The so-called active drug-eluting balloon could represent a new therapeutic option for the treatment of de novo lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Interventional revascularization of a coronary lesion,
- •Member or beneficiary of a social security system,
- •Informed of the study.
排除标准
- •Language barrier,
- •Pregnant woman,
- •Person under guardianship,
- •Person deprived of his/her liberty,
- •Refusal to participate.
结局指标
主要结局
Number of Major Adverse Cardiac Events (MACE)
时间窗: 12 months
The primary endpoint is a composite endpoint that includes major adverse cardiac events defined as cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke (stroke) and revascularization of target lesion (TLR) within 12 months of surgery.
次要结局
- Number of Major Adverse Cardiac Events (MACE)(36 months)