NCT07462546尚未招募不适用
Transcranial Doppler for Internal Carotid Artery Stenting (TCD-ICAS): A Prospective, Randomized Controlled, Blind Endpoint, Single-Center Study
General Hospital of Shenyang Military Region1 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2026年3月19日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- number of new Magnetic Resonance Imaging - Diffusion Weighted Imaging lesions
研究概览
简要总结
Carotid artery stenting (CAS) prevents stroke but carries risks of perioperative cerebral embolism. Transcranial Doppler (TCD) ultrasound can detect microemboli during CAS and may offer therapeutic benefits through ultrasound-enhanced thrombolysis. Trials like SONOBUSTER and SONOBIRDIE suggest TCD reduces new brain infarctions during carotid procedures. The TCD-ICAS trial will investigate whether TCD application during and after CAS reduces perioperative cerebral emboli and improves outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years old;
- •Patients with severe stenosis of the internal carotid artery;
- •Planned for carotid artery stent;
- •Modified Rankin Scale score ≤ 2;
- •The subject has adequate temporal bone windows to undergo TCD, and the blood flow signal of the middle cerebral artery is detectable.;
- •Signed informed consent by patient or their legally authorized representative.
排除标准
- •Comorbid conditions with severe infections or severe diseases of the liver, kidney, hematopoietic system, endocrine system, etc.;
- •Occurrence of intracranial hemorrhage (cerebral parenchymal hemorrhage, subarachnoid hemorrhage, subdural/epidural hemorrhage) within 90 days prior to enrollment;
- •Severe hematological disorders or significant coagulation abnormalities;
- •Pregnant or breastfeeding women;
- •Participation in another clinical trial within the past 3 months or ongoing participation;
- •Any other circumstances deemed by the investigator as unsuitable for participation in this clinical study.
研究组 & 干预措施
TCD group
Experimental
干预措施: Transcranial Doppler (Device)
Control group
No Intervention
结局指标
主要结局
number of new Magnetic Resonance Imaging - Diffusion Weighted Imaging lesions
时间窗: 24 (±8) hours
次要结局
- total volume of new Magnetic Resonance Imaging - Diffusion Weighted Imaging lesions(30±3 days)
- number of new Magnetic Resonance Imaging - Diffusion Weighted Imaging lesions >0.5 mL(30±3 days)
- composite of ischemic stroke, transient ischemic attack (TIA), or death(30±3 days)
- intracranial hemorrhage on neuroimaging(24 (±8) hours)
- serious adverse events(24 (±8) hours)
研究者
Hui-Sheng Chen
Director
General Hospital of Shenyang Military Region
研究点 (1)
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