SONOlysis in prevention of Brain InfaRctions During Internal carotid Endarterectomy (SONOBIRDIE) trial - study protocol for a randomized controlled trial.

ABSTRACT:

Background

Carotid endarterectomy (CEA) is a beneficial procedure for selected patients with an internal carotid artery (ICA) stenosis. Surgical risk of CEA varies from between 2 and 15%. The aim of the study is to demonstrate the safety and effectiveness of sonolysis (continual transcranial Doppler monitoring, TCD) using a 2-MHz diagnostic probe with maximal diagnostic energy on the reduction of the incidence of stroke, transient ischemic attack (TIA) and brain infarction detected using magnetic resonance imaging (MRI) by the activation of the endogenous fibrinolytic system during CEA.

Methods/design

Design: a multicenter, randomized, double-blind, sham-controlled trial.

Scope

international, multicenter trial for patients with at least 70% symptomatic or asymptomatic

SUBMITTER: Hrbac T 

PROVIDER: S-EPMC5240392 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature