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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCD group | Experimental |
| |
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Doppler | Device | TCD treatment (1.6 MHz, 0.274 MPa) from femoral artery puncture until 30-60 minutes after procedure completion |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of new Magnetic Resonance Imaging - Diffusion Weighted Imaging lesions | 24 (±8) hours |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, General Hospital of Northern Theater Command | Recruiting | Shenyang | 110016 | China |
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| ID | Term |
|---|---|
| D017585 | Ultrasonography, Doppler, Transcranial |
| ID | Term |
|---|---|
| D004453 | Echoencephalography |
| D009485 | Neuroradiography |
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
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| 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 |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011859 | Radiography |
| D014463 | Ultrasonography |
| D018608 | Ultrasonography, Doppler |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |