SONOBIRDIE Trial is a randomized, single-blind, sham-controlled study designed for a demonstration of the safety and effectiveness of sonolysis (continual transcranial Doppler (TCD) monitoring) in reduction of risk of stroke or transient ischemic attack (TIA), brain infarctions and cognitive decline using a 2-MHz diagnostic probe with a maximal diagnostic energy on the reduction of risk of brain infarctions by the activation of endogenous fibrinolytic system during carotid endarterectomy (CEA) in patients with ≥ 70% symptomatic or asymptomatic internal carotid artery stenosis. The sample size is based on an expected 2.5% reduction of ischemic stroke, TIA, and death during the 30-day postoperative period in the sonolysis group (estimated prevalence, 1.5 %) compared to the control group (estimated prevalence, 4 %). Pre-study calculations showed that a minimum of 746 patients in each group is needed to reach a significant difference with an alpha value of 0.05 (two-tailed) and a beta value of 0.8 assuming that 10 % would be lost to follow-up or refuse to participate in the study. Consecutive patients will be assigned to the sonolysis or control group by a computer-generated 1:1 randomization. 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 TCD probe with a maximal diagnostic energy. In patients randomized into control group, the TCD 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 TCD probe with a maximal diagnostic energy and the TCD monitoring will be stopped afterwards. Confirmation of the investigators hypothesis that sonothrombolysis is able to activate endogenous fibrinolytic system during CEA with consecutive reduction of ischemic stroke, TIA or death, and the number and volume of brain infarcts, can lead to the increase of the safety of CEA in patients with internal carotid artery stenosis. The investigators can presume that up to 50% of patients indicated for CEA can be treated using these methods in the future.
Age range
40 Years – 85 Years
Sex
ALL
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Occurence of ischemic stroke, transient ischemic attack and death within 30 days
Timeframe: 30 days after randomization