NCT03809754Unknown不适用
Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis: A Prospective Registry Trial
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2019年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- In-segment late loss at 9 months follow-up
研究概览
简要总结
This study is a prospective, registry trial aimed to compare the clinical and angiographic outcomes of OCT-guided and angiography-guided PCI in patients with coronary DES-ISR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 18 years or older
- •Patients with angina or evidence of myocardial ischaemia
- •Patients with restenotic lesions in a previously DES area of a coronary artery
- •Patients suitable to receive any types of percutaneous coronary intervention (including balloon angioplasty and stent implantation)
- •The stent diameter of DES-ISR is 2.5mm to 4.0mm
- •Target lesion length < 30mm
- •Target lesion stenosis ≥ 70% diameter stenosis on visual assessment, or ≥ 50% diameter stenosis and with evidence of myocardial ischaemia ischemic
排除标准
- •Patients with acute myocardial infarction with 1 week
- •Patients with evidence of extensive thrombosis in the target vessel
- •Patients with left main coronary artery disease
- •Patients with cardiogenic shock, left ventricular ejection fraction < 40%,significant renal dysfunction and severe heart valve disease
- •Patients who had cerebral stroke within 6 months before PCI
- •Patients with a life expectancy < 1 year
- •Patients not able to adhere to follow-up visits
结局指标
主要结局
In-segment late loss at 9 months follow-up
时间窗: 9 months
次要结局
- Rate of 9-month binary restenosis(9 months)
- Rate of myocardial infarction(12 months)
- Rates of acute success(1 month)
- Rate of major adverse cardiovascular events(12 months)
- Number of participants with all-cause death(12 months)
- Number of Participants with target lesion failure (TLF)(12 months)
研究者
Yun Dai Chen
Professor
Chinese PLA General Hospital
研究点 (1)
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