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

NCT07462546 | Recruiting DMC

• 1 other identifier: Y (2026) 13
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• number of new Magnetic Resonance Imaging - Diffusion Weighted Imaging lesions

  24 (±8) hours

Secondary Outcomes (5)

• 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

Study Arms (2)

TCD group

EXPERIMENTAL

Device: Transcranial Doppler

Control group

NO INTERVENTION

Interventions

Transcranial Doppler DEVICE

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

TCD group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

RECRUITING

MeSH Terms

Interventions

Ultrasonography, Doppler, Transcranial

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 10, 2026
• Study Start: March 24, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

CN (1)