SONOlysis in Prevention of Brain InfaRctions During Internal Carotid Endarterectomy

Summary

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.

Conditions

• Internal Carotid Artery Stenosis

Interventions

DEVICE

sonolysis

Continual transcranial Doppler monitoring of ipsilateral middle cerebral artery using a transcranial Doppler systems (e.g. DWL Multi-Dop T1, DWL, Sipplingen, Germany) with a diagnostic 2-MHz probe.

Sponsors & Collaborators

• Ústřední fakultní vojenská nemocnice, Praha, Czechia

  collaborator UNKNOWN

• Vítkovická nemocnice, Ostrava, Czechia

  collaborator UNKNOWN

• Masarykova nemocnice v Ústí nad Labem, Ústí nad Labem, Czechia

  collaborator UNKNOWN

• Nemocnice České Budějovice, České Budějovice, Czechia

  collaborator UNKNOWN

• Fakultní nemocnice Hradec Králové, Hradec Králové, Czechia

  collaborator UNKNOWN

• Fakultní nemocnice Plzeň, Plzeň, Czechia

  collaborator UNKNOWN

• Krajská nemocnice Liberec, Liberec, Czechia

  collaborator UNKNOWN

• Fakultná nemocnica Martin, Martin, Slovakia

  collaborator UNKNOWN

• Nemocnice Jihlava, Jihlava, Czechia

  collaborator UNKNOWN

• Nemocnice na Homolce, Praha, Czechia

  collaborator UNKNOWN

• Fakultní nemocnice Motol, Praha, Czechia

  collaborator UNKNOWN

• Fakultná nemocnica Nitra, Nitra, Slovakia

  collaborator UNKNOWN

• Fakultní nemocnice Olomouc, Olomouc, Czechia

  collaborator UNKNOWN

• Fakultná nemocnica Košice, Košice, Slovakia

  collaborator UNKNOWN

• Krajská nemocnice T. Bati, Zlín, Czechia

  collaborator UNKNOWN

• Allgemeine Krankenhausl Linz, Linz, Austria

  collaborator UNKNOWN

• University Hospital Ostrava

  lead OTHER

Principal Investigators

• David Skoloudik, MD,PhD,FESO · Department of Neurology, University Hospital Ostrava

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-31

Primary Completion

2022-11-30

Completion

2022-12-01

Countries

• Czechia

Study Locations