NCT03780192Unknown不适用
INSPIRON Sirolimus Eluting Stent Performance in Bifurcation Coronary Arteries Treated Using Provisional Technique
Scitech Produtos Medicos Ltda1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年2月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percentage of Stenosis
研究概览
简要总结
Evaluate the efficacy of the Inspiron Sirolimus Eluting Stent on bifurcation coronary artery lesions, in order to preserve and not compromize the side branch using the provisional stent technique.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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 coronary artery disease on bifurcation anatomy with indication of drug eluting stent implantation , on which the side branch is ≥ 2.5 mm diameter and ostial stenosis ≤50% (Medina 1-1-0, 1-0-0, 0-1-0).
排除标准
- •Acute Myocardial Infarction (STMI);
- •Chronic occlusion;
- •Cardiogenic shock;
- •Ejection fraction ≤ 20%;
- •Thrombocytopenia (≤ 50 mil);
- •DAPT contraindication;
- •Life expectancy of less than 12 months.
结局指标
主要结局
Percentage of Stenosis
时间窗: day 0
% of stenosis on side branch after stent placement on main vessel
次要结局
未报告次要终点
研究者
Marco Vugman Wainstein
Principal Investigator Hospital Moinhos de Vento
Scitech Produtos Medicos Ltda
研究点 (1)
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