Intravascular Ultrasound Versus Angiography Guided Drug-eluting Stent Implantation for Patients With Coronary Severe Calcification: a Prospective, Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 864
- 试验地点
- 1
- 主要终点
- the rate of target-vessel failure at 12 months
研究概览
简要总结
Coronary calcified lesion is associated with a poor clinical outcome. Intravascular ultrasound (IVUS) provides anatomic information in detail about reference vessel dimensions and lesion characteristics including severity of diameter stenosis, lesion length, and morphology. Both randomized and observational studies have reported the clinical benefits of IVUS guidance for patients with chronic total occlusion (CTO), long lesions, acute coronary syndrome (ACS) with complex bifurcation lesions. Our previous ULTIMATE trial has demonstrated that IVUS-guided drug-eluting stent (DES) implantation significantly improved clinical outcome in all-comers, particularly for patients who had an IVUS-defined optimal procedure, compared with angiography guidance. However, the benefit of IVUS guidance in coronary severe calcification still remains unknown in the modern DES era.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Silent ischemia, stable or unstable angina, non-ST-segment elevation myocardial infarction > 48 hours, or ST-segment elevation myocardial infarction > 7 days;
- •De novo coronary lesion eligible for drug-eluting stent implantation;
- •Target lesion with severe calcification;
排除标准
- •Age less than 18-year-old;
- •Comorbidity with a life expectancy <12 months;
- •Intolerant of antithrombotic therapy;
- •Significant anemia, thrombocytopenia, or leucopenia;
- •History of major hemorrhage (intracranial, gastrointestinal, and so on);
- •Chronic total occlusion lesion not recanalized;
- •Scheduled major surgery in the next 12 months;
- •Left ventricular ejection fraction < 25%;
- •Uremia dependent on dialysis treatment;
- •Previous drug-eluting stent implantation in target vessel;
结局指标
主要结局
the rate of target-vessel failure at 12 months
时间窗: 12 months after indexed procedure
the composite of cardiovascular death, target-vessel myocardial infarction, and clinically driven target-vessel revascularization
次要结局
未报告次要终点
研究者
Junjie Zhang
Vice chief
Nanjing First Hospital, Nanjing Medical University