SONOlysis in Prevention of Brain InfaRctions During Internal Carotid Endarterectomy (SONOBIRDIE)
Internal Carotid Artery Stenosis
About this trial
This is an interventional treatment trial for Internal Carotid Artery Stenosis focused on measuring sonolysis, carotid endarterectomy, stroke prevention, brain infarction
Eligibility Criteria
Inclusion Criteria:
- Subject has a symptomatic or asymptomatic ICA stenosis ≥ 70 % (NASCET criteria) as detected by a duplex sonography (see Appendix) and confirmed using the computed tomography angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography (DSA).
- Subject is indicated for CEA according to the criteria set by the American Heart Association.
- Subject is aged 40 - 85 years.
- Subject has a sufficient temporal bone window for TCD with detectable blood flow in the MCA.
- Subject is functionally independent with a modified Rankin score value of 0 - 2 points.
- Informed consent is signed by the subject.
Exclusion Criteria:
- Subject has been participating in another clinical trial within last 6 weeks.
- Subject has any other medical condition that would make him/her inappropriate for study participation, in the Investigator opinion.
Sites / Locations
- University Hospital Ostrava
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Sonolysis
Shame sonolysis
In patients randomized into sonolysis group, middle cerebral artery segment in a depth of 55 mm will be continuously monitored during intervention using a diagnostic 2-MHz transcranial Doppler probe with a maximal diagnostic energy. The probe will be fixed in a required position using a special helmet and sonolysis will start before the carotid intervention and will be stopped after the intervention, but at latest after 120 minutes. Transcranial Doppler machine with a 2-MHz diagnostic transcranial Doppler probe will be used. This non-diagnostic transcranial Doppler monitoring will be performed without detection of microembolic signals or detection of changes in blood flow. Device sound and Doppler wave imaging will be switched off. Only sonographer will be unblinded to the procedure.
In patients randomized into control group, the transcranial Doppler probe will be fixed in a required position using a special helmet as in sonolysis group patients, but middle cerebral artery segment in a depth of 55 mm will be only localized using a diagnostic 2-MHz transcranial Doppler probe with a maximal diagnostic energy and the transcranial Doppler monitoring will be stopped afterwards. Patients in the control group will undergo a sham procedure in which further sonolysis (transcranial Doppler monitoring) will not be conducted.