Carotid Revascularization Versus Best Medical Treatment for Asymptomatic Carotid Stenosis: a Multicenter, Open, Randomized Controlled Trial in Chinese Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,056
- 试验地点
- 11
- 主要终点
- Any Periprocedural Stroke, Myocardial Infarction, or Death During1 month Peri-procedural Period, and Postprocedural Ipsilateral Stroke 1 to 12-months.
研究概览
简要总结
This is a multicenter, open, randomized controlled trial to evaluate the efficacy and safety of carotid artery stenting/carotid endarterectomy versus best medical treatment for asymptomatic carotid artery stenosis in Chinese population.
详细描述
This is a multicenter, open, randomized controlled trial to evaluate the efficacy and safety of carotid artery stenting/carotid endarterectomy versus best medical treatment for asymptomatic carotid artery stenosis in Chinese population. The study will be conducted at 11 centers and is expected to enroll 1056 patients.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-80 years;
- •Carotid artery stenosis 50%-90% (ultrasound, CT, or DSA);
- •Asymptomatic carotid stenosis, that is, no transient ischemic attack, stroke, or other neurological symptoms in the past 6 months;
- •Patients who could complete 12 months of follow-up;
- •Patients who signed informed consent forms.
排除标准
- •Patients who had a TIA, stroke, or other related neurological symptoms within the previous 6 months;
- •Patients with spontaneous intracerebral hemorrhage in the past 12 months；
- •Patients with large intracranial aneurysms (diameter> 5mm)，and cannot be treated in advance or contemporaneous;
- •Chronic total occlusion without obvious cerebral ischemia symptoms；
- •Patients with neurologic disorder that caused transient or permanent neurological deficits and can not be identified with transient ischemic attack or stroke；
- •Patients with severe dementia;
- •Common carotid artery opening lesion；
- •Severe intracranial stenosis in tandem;
- •Carotid artery dissection;
- •Carotid artery aneurysm;
- •Myocardial infarction occurred within 30 days；
- •It is known that two or more proximal or main coronary artery stenosis ≥70%, untreated or unable to recanalize;
- •Ejection fraction <30% or New York Heart Association (NYHA) functional class III or higher；Unstable angina，ie angina at resting state and electrocardiogram changes；
- •Patients with cardiac emboli sources, such as left ventricular aneurysm, intraluminal filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, infective endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma；
- •Platelet count <5×104/μL, INR>1.5, Bleeding time > 1 min, or heparin-related thrombocytopenia；Patients contraindicated to heparin and antiplatelet drugs;
- •Patients with coagulation dysfunction.
- •Poor control of diabetes, fasting blood glucose >22mmol/L and ketone body > +2；
- •Malignant tumor or respiratory insufficiency, life expectancy < 5 years.
- •Insufficiency of vital organs: forced expiratory volume at one second < 30% (predicted)； dialysis-dependent renal failure; intolerance to anesthesia;
- •Currently waiting main organ transplants (ie heart, lung, liver, kidney), or are doing relevant evaluate；
- •Need to perform other general anesthesia surgery during the same period；
- •Pregnant or lactating women；
- •Those who participated in clinical trials of other drugs or medical devices before the inclusion did not reach the end of the time limit；
- •Investigators consider the patient inappropriate to participate in this clinical trial；
研究组 & 干预措施
Carotid Revascularization
Carotid Artery Stenting/Carotid endarterectomy + Best Medical Treatment
干预措施: Carotid Revascularization (Procedure)
Carotid Revascularization
Carotid Artery Stenting/Carotid endarterectomy + Best Medical Treatment
干预措施: Medical Treatment (Drug)
Medical Treatment
Best Medical Treatment
干预措施: Medical Treatment (Drug)
结局指标
主要结局
Any Periprocedural Stroke, Myocardial Infarction, or Death During1 month Peri-procedural Period, and Postprocedural Ipsilateral Stroke 1 to 12-months.
时间窗: 0 to 12 months
Composite of any periprocedural stroke (ipsilateral or contralateral; major or minor), myocardial infarction, or death during1 month peri-procedural period, and postprocedural ipsilateral stroke 1 to 12-months.
次要结局
- Carotid restenosis rate(12 months)
- Technical success rate(1 day)
- Rate of complications(30 days)
- Incidence of myocardial infarction(30 days)
- Incidence of ipsilateral stroke(30 days)
- Incidence of death(30 days)
- Incidence of target lesion revascularization(12 months)
- Improvement in cognitive function(12 months)