NCT02871622Unknown不适用
A Post-market Registry of the BioMatrix Alpha TM (Cobalt Chromium Biolimus A9TM (BA9TM) Drug-eluting Stent)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or clinically driven target vessel revascularization (TVR).
研究概览
简要总结
Prospective, multi-center, registry designed to enrol up to 2,000 patients in up to 35 International centers. All patients will receive a BioMatrix AlphaTM stent as per clinical practice and will be followed for 2 years for data collection. Major adverse cardiac events (MACE) results at 9 months will be compared to the results obtained from the BioMatrix FlexTM arm of the LEADERS trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated with the BioMatrix AlphaTM stent per clinical indication and physician's choice;
- •Patients who agree to comply with the follow up requirements;
- •Patients with a life expectancy of > 1 year at time of consent;
- •Patients eligible to receive dual anti platelet therapy (DAPT) according to guidelines;
- •Hemodynamically stable patients.
排除标准
- •Inability to provide informed consent;
- •Currently participating in another trial before reaching primary endpoint;
- •Planned surgery within 6 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the perisurgical period;
- •Patient has received an additional stent different from a BioMatrix AlphaTM stent during the index procedure.
结局指标
主要结局
Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or clinically driven target vessel revascularization (TVR).
时间窗: 9 months
次要结局
未报告次要终点
研究者
研究点 (1)
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