Evaluation of the Strategy of "One-stop" Endovascular Treatment for Concomitant Coronary Artery Disease and Aortic Atherosclerotic Disease
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Perioperative major bleeding (BARC≥3 grade)
研究概览
简要总结
The study is a prospective, randomized, controlled, exploratory trail to evaluate the strategy of "one-stop" endovascular treatment for concomitant coronary artery disease and aortic atherosclerotic disease.
详细描述
60 patients will be allocated randomly in a 1:1 ratio into one-stop strategy group or staging strategy group. In one-stop strategy group, percutaneous coronary intervention (PCI) will be performed on the same operating room immediately after the endovascular aortic repair (EVAR); In staging strategy group, PCI will be performed several days after EVAR. The safety and effectiveness will be assessed between two groups 1 year after the operation. The economic index will be evaluated as well as.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 18 years to 75years, male or female;
- •Aortic atherosclerotic disease with indication of EVAR;
- •Coronary heart disease with indication of PCI;
- •Provided informed consent.
排除标准
- •Acute aortic dissection
- •Acute coronary syndrome
- •Dysfunction of coagulation system
- •Patients with gastrointestinal hemorrhage
- •Known allergy to contrasts or antiplatelet drugs
- •Renal dysfunction (GFR≤60ml/min)
- •Patient with multi-branch coronary preferred CABG
结局指标
主要结局
Perioperative major bleeding (BARC≥3 grade)
时间窗: 12 months
次要结局
- Difference of incidence of bleeding events (BARC 2 grade) between two groups(12 months)
- Difference of incidence of all-cause death between two groups(12 months)
- Difference of incidence of myocardial infarction between two groups(12 months)
- Difference of operative success rate between two groups(12 months)
- Difference of incidence of Stent thrombosis between two groups(12 months)
- Composite of average in-patient time and average cost during hospitalization(12 months)
- Difference of incidence of rupture of aorta between two groups(12 months)
- Difference of incidence of pseudoaneurysm between two groups(12 months)
研究者
Yi-Da Tang
Clinical professor
Chinese Academy of Medical Sciences, Fuwai Hospital