A Prospective, Multi-center, Randomized Trial Comparing Two-stent With Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 660
- 试验地点
- 1
- 主要终点
- Target lesion failure
研究概览
简要总结
The purpose of this study is to establish the optimal strategy for stenting in coronary bifurcation lesion.
详细描述
The current study is designed as a multicenter, randomized and prospective study aiming to compare the effect of two-stenting and simple stenting techniques in patients with complex bifurcation lesions. Based on the previous studies, the rate of 1-year target lesion failure events was around 14% after PCI with provisional stenting. And our previous data showed that this event at 12-month after two-stenting procedure was 7%. Considering the lost to follow-up, it is anticipated that up to 660 patients will be enrolled in the trial. All patients will have repeat angiography at 13 months, with clinical follow-up to 5 years.
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
- Double (Participant, 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;
- •True bifurcation lesions (Medina 0,1,1/1,1,1);
- •Reference vessel diameter in side branch ≥2.5mm by visual estimation;
- •Complex bifurcation lesions based on DEFINITION study.
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;
- •Unable to provide written informed consent, or fail to follow the protocol;
- •Previous enrolment in coronary intervention device investigation during the study period;
- •Patient with STEMI within 24-hour from the onset of chest pain to admission;
- •Restenosis bifurcation lesions.
结局指标
主要结局
Target lesion failure
时间窗: 12 months
Combined end point of: cardiac death, target-vessel myocardial infarction (MI), or target lesion revascularization (TLR).
次要结局
- Stent thrombosis(12 months)
- Target-vessel myocardial infarction(12 months)
- Target vessel revascularisation(12 months)
- Cardiac death(12 months)
- Target lesion revascularisation(12 months)
研究者
Shaoliang Chen
Vice President
Nanjing First Hospital, Nanjing Medical University