Transcranial Doppler for Internal Carotid Artery Stenting (TCD-ICAS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial Doppler.
- Who it may be relevant to
- Registry conditions: Artery Stenosis. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Transcranial Doppler for Internal Carotid Artery Stenting (TCD-ICAS): A Prospective, Randomized Controlled, Blind Endpoint, Single-Center Study
Overview
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
- Device Transcranial Doppler
TCD treatment (1.6 MHz, 0.274 MPa) from femoral artery puncture until 30-60 minutes after procedure completion
Primary outcome measures
- number of new Magnetic Resonance Imaging - Diffusion Weighted Imaging lesions [Time frame: 24 (±8) hours]
Secondary outcome measures (5)
- total volume of new Magnetic Resonance Imaging - Diffusion Weighted Imaging lesions [Time frame: 30±3 days]
- number of new Magnetic Resonance Imaging - Diffusion Weighted Imaging lesions >0.5 mL [Time frame: 30±3 days]
- composite of ischemic stroke, transient ischemic attack (TIA), or death [Time frame: 30±3 days]
- intracranial hemorrhage on neuroimaging [Time frame: 24 (±8) hours]
- serious adverse events [Time frame: 24 (±8) hours]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Department of Neurology, General Hospital of Northern Theater Command — Shenyang
Identifiers
NCT: NCT07462546 · Y (2026) 13