Using Transcranial Doppler to Detect and Reduce Emboli During Carotid Stenting

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

This trial will test whether using transcranial Doppler ultrasound during and after carotid artery stenting can detect and reduce tiny brain emboli in people aged 40 and older with severe internal carotid artery narrowing.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 232 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: General Hospital of Shenyang Military Region (other)
• Locations: 1 site (Shenyang)
• Trial ID: NCT07462546 on ClinicalTrials.gov

What this trial studies

Transcranial Doppler (TCD) ultrasound will be used during the carotid stent procedure and in the immediate postoperative period to detect microembolic signals and, when possible, deliver ultrasound-enhanced thrombolytic effects. Eligible participants are adults with severe internal carotid artery stenosis who have an adequate temporal bone window and are scheduled for carotid artery stenting. The study will track perioperative cerebral emboli, new brain infarctions on imaging, and short-term neurological outcomes after the procedure. The approach builds on prior trials that suggested TCD monitoring may lower the rate of new infarctions during carotid procedures and aims to see if similar benefits occur in this patient group.

Who should consider this trial

Good fit: Adults aged 40 or older with severe internal carotid artery stenosis scheduled for carotid artery stenting, a modified Rankin Scale score of 0–2, an adequate temporal bone window for TCD, and ability to give consent are ideal candidates.

Not a fit: Patients with recent intracranial hemorrhage, severe systemic organ disease or coagulation disorders, pregnancy or breastfeeding, those without a usable temporal bone window, or those otherwise judged unsuitable by investigators are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could lower the number of perioperative cerebral emboli and reduce new brain infarctions and stroke risk after carotid stenting.

How similar studies have performed: Previous trials such as SONOBUSTER and SONOBIRDIE have reported that TCD during carotid procedures can reduce new brain infarctions, so this approach has supportive but not definitive prior evidence.

Eligibility criteria

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.

Where this trial is running

Shenyang

• Department of Neurology, General Hospital of Northern Theater Command — Shenyang, China (RECRUITING)

Conditions: Artery Stenosis