A Controlled Clinical Study of Carotid Artery Stent Implantation in the Treatment of Vulnerable Plaque
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Perioperative 30-day stroke rate
研究概览
简要总结
To investigate the efficacy and safety of carotid stenting for vulnerable carotid plaques. All patients with carotid artery stenosis underwent carotid arterial contrast-enhanced ultrasonography before operation. According to the examination results, they were divided into two groups: vulnerable plaque group and stable plaque group. The incidence of perioperative stroke events in the two groups was compared. The incidence of stroke events in the two groups within 1 year was compared.
详细描述
- To enroll 100 cases of patients suffering from carotid artery stenosis。the investigators perform contrast enhanced ultrasound on patients for identifying the vulnerable plagues
- The investigators divide patients into the stable group and the vulnerable group based on the results of CEUS inspection.
- All patients undergo carotid stent. To analysis the incidence of postoperative complications such as stroke and mortality within 30 days and to compare the differences between the two groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients with ischemic symptom whose carotid stenosis were more than 50%
- •The patients without ischemic symptom whose carotid stenosis were more than 70%
排除标准
- •• Confirmed with severe intracranial vascular lesions
- •Suffering from the large area cerebral infarction or critical stroke sequela
- •Restenosis after CEA or CAS
- •Suffering from severe coronary heart disease, respiratory failure,the hypertension difficult to controled
- •Patients with malignant tumor or expected life < 2 years
结局指标
主要结局
Perioperative 30-day stroke rate
时间窗: 30 days
To determine whether there is a new cerebral infarction by postoperative re-examination of brain MRI and preoperative brain MRI
次要结局
- 1-year stroke rate after surgery(1 year)
研究者
Keqiang Zhao
Attending Doctor
Beijing Tsinghua Chang Gung Hospital
