BiOSS LIM C Stent Registry in Bifurcated Lesions
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- MACE
研究概览
简要总结
The BIOSS Lim C pharmacoactive Stent has characteristics of design that makes it very suitable for the treatment of bifurcational lesions . The objective of the study is providing deeper knowledge into the results of this stent in the treatment of bifurcational lesions.
详细描述
The BIOSS Lim C pharmacoactive Stent has characteristics of design that makes it very suitable for the treatment of bifurcational lesions . The objective of the study is providing deeper knowledge into the results of this stent in the treatment of bifurcational lesions.
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
- •Age over 18 years.
- •Clinical indication of coronary angioplasty in bifurcated lesion.
- •Bifurcated lesions with both distal branches at least 2 mm in diameter.
- •The lesion must be located in the main branch, with a severe stenosis by visual estimation at some point in the main branch, with or without involvement of the lateral branch.
- •Express acceptance and signature of informed consent.
排除标准
- •Express rejection of the patient to participate in the study.
- •Exclusive involvement of the lateral branch (Medina lesion 001).
- •Contraindication for antiplatelet treatment.
- •Lesions due to restenosis.
- •Lesions in saphenous grafts.
- •Total chronic occlusions.
- •Cardiogenic shock.
结局指标
主要结局
MACE
时间窗: 1 year
Cumulative rate of major adverse cardiovascular events (MACE) including cardiac
Successful angioplasty
时间窗: 1 day
After angiography: TIMI (thrombolysis in myocardial infarction ) 3 (both branches). With respect to reference diameter, none of the segments treated with stent has a residual stenosis\> 30% or\> 50% in those not treated with stent.
次要结局
- Target vessel revascularization(30 days)
- contrast media volume(1 day)
- Percentage of stent struts malposition(30 days)
- Angioplasty time(1 day)