Evaluation of the Strategy of "One-stop" Endovascular Treatment for Concomitant Coronary Artery Disease and Aortic Atherosclerotic Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Treatment-Emergent Adverse Events
研究概览
简要总结
The study is designed to evaluate the safety and effectiveness of the "one-stop" endovascular intervention strategy for patients with concomitant coronary artery disease and aortic atherosclerotic disease. It is a registration study, which will consecutively enroll at least 50 patients with at least 30 subjects receiving one-stop strategy.
详细描述
It is a registration study, at least 50 patients will be consecutively enrolled and then be allocated into one-stop strategy group or staging strategy group with at least 30 subjects receiving one-stop strategy. In one stop strategy group, percutaneous coronary intervention (PCI) will be performed on the same operating table 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 the two groups untill 1 year after the operation. The economic index will be evaluated.
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 75 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 the indication of EVAR;
- •Coronary heart disease with the 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
研究组 & 干预措施
One stop strategy group
Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR)
干预措施: One stop strategy group (Procedure)
Staging strategy group
PCI will be performed several days after EVAR
结局指标
主要结局
Treatment-Emergent Adverse Events
时间窗: 12 months
The incidence of a composite endpoint of all-cause mortality, myocardial infarction, rupture of aorta, hematoma, bleeding events (BARC≥2 grade), pseudoaneurysm, stent thrombosis
次要结局
- Average cost during hospitalization(12 months)
- Operative success rate(12 months)
- Average in-patient time(12 months)
研究者
Yi-Da Tang
Clinical professor
Chinese Academy of Medical Sciences, Fuwai Hospital