Artery StenosisNCT07462546
Transcranial Doppler for Internal Carotid Artery Stenting (TCD-ICAS)
A study testing Transcranial Doppler in people with Artery Stenosis, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Artery Stenosis
- What is being tested?
- Transcranial Doppler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, 110016
Hui-Sheng Chen, Ph.D., +86 13352452086, chszh@aliyun.com
About this study
Official title: 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.
- Conditions
- Artery Stenosis
- Being tested
- Transcranial Doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial DopplerDevice
TCD treatment (1.6 MHz, 0.274 MPa) from femoral artery puncture until 30-60 minutes after procedure completion
| Study group | Role | What they receive |
|---|---|---|
| TCD group | Experimental | Not described Receives: Device: Transcranial Doppler |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of new Magnetic Resonance Imaging - Diffusion Weighted Imaging lesions
Measured: 24 (±8) hours
Secondary outcomes (5)
total volume of new Magnetic Resonance Imaging - Diffusion Weighted Imaging lesions
Measured: 30±3 days
number of new Magnetic Resonance Imaging - Diffusion Weighted Imaging lesions >0.5 mL
Measured: 30±3 days
composite of ischemic stroke, transient ischemic attack (TIA), or death
Measured: 30±3 days
intracranial hemorrhage on neuroimaging
Measured: 24 (±8) hours
serious adverse events
Measured: 24 (±8) hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start24 Mar 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462546
- Sponsor's protocol ID
- Y (2026) 13
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang Y, Wang YJ, Wang L, Wang TT, Chen HS. Transcranial Doppler for internal carotid artery stenting: rationale and design of a randomized controlled trial. Front Neurol. 2026 Aug 18;17:1843954. doi: 10.3389/fneur.2026.1843954. eCollection 2026.
PubMed 42682504
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Doppler for Internal Carotid Artery Stenting (TCD-ICAS): A Prospective, Randomized Controlled, Blind Endpoint, Single-Center Study
- ClinicalTrials.gov ID
- NCT07462546
- Acronym / sponsor ID
- Y (2026) 13
- Conditions
- Artery Stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCD group | Experimental | Device: Transcranial Doppler |
| Control group | No intervention | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial DopplerTCD treatment (1.6 MHz, 0.274 MPa) from femoral artery puncture until 30-60 minutes after procedure completion | Device | TCD group |
Primary outcome
number of new Magnetic Resonance Imaging - Diffusion Weighted Imaging lesions
Time frame: 24 (±8) hours
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Derived from this study: PubMed 42682504Wang Y, Wang YJ, Wang L, Wang TT, Chen HS. Transcranial Doppler for internal carotid artery stenting: rationale and design of a randomized controlled trial. Front Neurol. 2026 Aug 18;17:1843954. doi: 10.3389/fneur.2026.1843954. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Doppler in people with Artery Stenosis, run by General Hospital of Shenyang Military Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of new Magnetic Resonance Imaging - Diffusion Weighted Imaging lesions (time frame: 24 (±8) hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07462546, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.