Transcranial Doppler for Internal Carotid Artery Stenting (TCD-ICAS)

Transcranial Doppler for Internal Carotid Artery Stenting (TCD-ICAS): A Prospective, Randomized Controlled, Blind Endpoint, Single-Center Study

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.