跳至主要内容
临床试验/NCT05524207
NCT05524207招募中不适用

A Controlled Clinical Study of Carotid Artery Stent Implantation in the Treatment of Vulnerable Plaque

Beijing Tsinghua Chang Gung Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年1月1日最近更新:
适应症

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

  1. To enroll 100 cases of patients suffering from carotid artery stenosis。the investigators perform contrast enhanced ultrasound on patients for identifying the vulnerable plagues
  2. The investigators divide patients into the stable group and the vulnerable group based on the results of CEUS inspection.
  3. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Keqiang Zhao

Attending Doctor

Beijing Tsinghua Chang Gung Hospital

研究点 (1)

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