NCT06168422招募中不适用
A Cohort Study of PCI Strategies for Severely Calcified Lesions of Complex Coronary Arteries in the Elderly
Henan Institute of Cardiovascular Epidemiology1 个研究点 分布在 1 个国家目标入组 2,100 人开始时间: 2023年12月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,100
- 试验地点
- 1
- 主要终点
- MACEs
研究概览
简要总结
The aim of this observational study is to compare the prognostic outcomes of various PCI strategies in elderly patients with complex coronary calcified lesions. The patients will be classified into two groups and assigned different PCI strategies, either stenting or stenting combined with pharmacologic balloon implantation. The investigators will assess the one-year prognosis for major adverse cardiovascular events in these patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years;
- •Meet the indications for coronary intervention;
- •IVUS examination suggests severe calcified lesions (calcification angle >270°) or OCT examination suggests severe calcified lesions (calcification angle >180° and/or length >5mm and/or thickness >0.5mm);
- •The diameter of the target lesion vessel is greater than 2.75mm;
- •The total length of the lesion is more than 60mm and/or the number of lesions to be treated is ≥3 and/or the number of vessels to be treated is ≥2.
排除标准
- •inability to provide written informed consent;
- •inability to administer antiplatelet agents and anticoagulant therapy;
- •the subject is participating in other unfinished clinical trials;
- •life expectancy <1 year;
- •non-in situ vascular lesions;
- •patients with haemodynamic instability;
- •Previous stroke within 6 months.
- •left main stem lesions.
结局指标
主要结局
MACEs
时间窗: 12 months
A Composite Event Including Cardiac Death, Myocardial Infarction, Stroke, and Target Vessel Revascularization
次要结局
- Cardiac Death(12 months)
- Myocardial Infarction(12 months)
- Target Vessel Revascularization(12 months)
- Stroke(12 months)
- BRCA 2,3-5(12 months)
研究者
研究点 (1)
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