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

March 24, 2026 updated by: Hui-Sheng Chen, General Hospital of Shenyang Military Region

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

232

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shenyang, China, 110016
        • Recruiting
        • Department of Neurology, General Hospital of Northern Theater Command
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: TCD group
Device: Transcranial Doppler
TCD treatment (1.6 MHz, 0.274 MPa) from femoral artery puncture until 30-60 minutes after procedure completion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of new Magnetic Resonance Imaging - Diffusion Weighted Imaging lesions
Time Frame: 24 (±8) hours
24 (±8) hours

Secondary Outcome Measures

Outcome Measure
Time Frame
total volume of new Magnetic Resonance Imaging - Diffusion Weighted Imaging lesions
Time Frame: 30±3 days
30±3 days
number of new Magnetic Resonance Imaging - Diffusion Weighted Imaging lesions >0.5 mL
Time Frame: 30±3 days
30±3 days
composite of ischemic stroke, transient ischemic attack (TIA), or death
Time Frame: 30±3 days
30±3 days
intracranial hemorrhage on neuroimaging
Time Frame: 24 (±8) hours
24 (±8) hours
serious adverse events
Time Frame: 24 (±8) hours
24 (±8) hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Shenyang Military Region

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Y (2026) 13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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