Sonolysis during carotid endarterectomy: randomised controlled trial.

ABSTRACT:

Objective

To evaluate the effectiveness and safety of sonolysis using a low intensity 2 MHz pulsed wave ultrasound beam during carotid endarterectomy.

Design

Multicentre, phase 3, double blind, randomised controlled trial.

Setting

16 European centres.

Participants

1004 patients (mean age 68 years; 312 (31%) female) were enrolled in the study between 20 August 2015 and 14 October 2020 until the interim analysis was performed.

Interventions

Sonolysis (n=507) versus sham procedure (n=497).

Main outcome measures

The primary endpoint was the composite incidence of ischaemic stroke, transient ischaemic attack, and death within 30 days. The incidence of new ischaemic lesions on follow-up brain magnetic resonance imaging was the main substudy endpoint, an

SUBMITTER: Skoloudik D 

PROVIDER: S-EPMC11921150 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature