Health TrialsbyHealthPanel

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

ConditionArtery Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorGeneral Hospital of Shenyang Military Region

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 40 years old;

Patients with severe stenosis of the internal carotid artery;

Planned for carotid artery stent;

Modified Rankin Scale score ≤ 2;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcranial Doppler

    Device

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

Treatment groups

232 Participants
are divided into 2 treatment groups
Group A: TCD groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

General Hospital of Shenyang Military Region

Lead sponsor

Source ClinicalTrials.gov
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