Artery Stenosis
Conditions
Brief summary
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.
Interventions
DEVICETranscranial Doppler
TCD treatment (1.6 MHz, 0.274 MPa) from femoral artery puncture until 30-60 minutes after procedure completion
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of new Magnetic Resonance Imaging - Diffusion Weighted Imaging lesions | 24 (±8) hours |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed