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NCT Number: NCT07462546

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

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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Key information

Conditions

Artery Stenosis

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

Location status: Recruiting

Location contact

Hui-Sheng Chen, Ph.D.

CONTACT

[email protected]

+86 13352452086

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial Doppler

Device

TCD treatment (1.6 MHz, 0.274 MPa) from femoral artery puncture until 30-60 minutes after procedure completion

Primary outcomes

  1. number of new Magnetic Resonance Imaging - Diffusion Weighted Imaging lesions

    Time frame: 24 (±8) hours

Secondary outcomes

  1. total volume of new Magnetic Resonance Imaging - Diffusion Weighted Imaging lesions

    Time frame: 30±3 days

  2. number of new Magnetic Resonance Imaging - Diffusion Weighted Imaging lesions >0.5 mL

    Time frame: 30±3 days

  3. composite of ischemic stroke, transient ischemic attack (TIA), or death

    Time frame: 30±3 days

  4. intracranial hemorrhage on neuroimaging

    Time frame: 24 (±8) hours

  5. serious adverse events

    Time frame: 24 (±8) hours

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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