Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-comers" Coronary Lesions （ULTIMATE Trial）
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,448
- 试验地点
- 1
- 主要终点
- Target Vessel Failure
研究概览
简要总结
A number of 1448 patients scheduled for elective percutaneous coronary intervention (PCI) with a native coronary stenosis suitable for DES implantation and IVUS imaging are openly randomized 1:1 to either IVUS guidance or angiographic guidance groups.
详细描述
The study is prospectively conducted at 8 high-volume PCI centers in China with IVUS expertise. Clinic follow-up are planned in all patients 12 months after implantation of drug eluting stents. Primary endpoint is target vessel failure. The study is powered for primary endpoint, which are likely to reach significance at the level P < 0.05 even at a follow-up drop-out rate up to 10%.
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
- Single (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
- •Provision of informed consent prior to any study specific procedures;
- •Men and women 18 years and older;.
- •Established indication to PCI according to the guidelines of American Heart Association and American College of Cardiology;
- •Native coronary lesion suitable for drug-eluting stent placement and IVUS imaging.
排除标准
- •Pregnancy and breast feeding mother;
- •Co-morbidity with an estimated life expectancy of < 50 % at 12 months;
- •Scheduled major surgery in the next 12 months;
- •Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
- •Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days;
- •Known allergy against ticagrelor, or against clopidogrel, or aspirin History of major hemorrhage (intracranial, gastrointestinal, etc.);
- •Chronic total occlusion lesion in either LAD, or LCX or RCA not re-canalized;
- •Severe calcification needing rotational atherectomy；
- •Patient with STEMI (within 24-hour from the onset of chest pain to admission).
结局指标
主要结局
Target Vessel Failure
时间窗: 12 months
The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization.
次要结局
- Mortality(12 months)
- Cardiac death(12 months)
- Myocardial infarction(12 months)
- Target vessel revascularization(12 months)
- Target lesion revascularization(12 months)
研究者
Shaoliang Chen
Director of Cardiology and Cath Lab, Vice President of Nanjing First Hospital, Nanjing Medical University
Nanjing First Hospital, Nanjing Medical University