Evidence map›Paper›PMID 40107675›Full record

Trial reportBMJ (Clinical research ed.)2025

Sonolysis during carotid endarterectomy: randomised controlled trial.

David Školoudík, Tomáš Hrbáč, Martin Kovář, Vladimír Beneš, Jiří Fiedler, Mattia Branca, Jean-Benoit Rossel, David Netuka, SONOBIRDIE Trial Investigators

Erratum issued Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in BMJ (Clinical research ed.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02398734 (Risk Reduction of Symptomatic and Silent Brain Infarctions During Carotid Endarterectomy by the Ultrasound Activation of Endogenous Fibrinolytic System Using Sonolysis), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02398734 nacompletednot on this map

Risk Reduction of Symptomatic and Silent Brain Infarctions During Carotid Endarterectomy by the Ultrasound Activation of Endogenous Fibrinolytic System Using Sonolysis (Transcranial Doppler Monitoring)

TypeinterventionalSponsorUniversity Hospital OstravaRan2015 to 2022Enrolled1,492ConditionsInternal Carotid Artery StenosisArmssonolysis
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Low-intensity ultrasound lysis of amyloid microclots in a lab-on-chip model.Frontiers in bioengineering and biotechnology · 2025
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

David ŠkoloudíkCentre for Health Research, Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic skoloudik@email.cz.ORCID 0000-0002-2651-3424
Tomáš HrbáčCentre for Health Research, Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.
Martin KovářDepartment of Neurology, Na Homolce Hospital, Prague, Czech Republic.
Vladimír BenešDepartment of Neurosurgery, Second Faculty of Medicine, Charles University and University Hospital Motol, Prague, Czech Republic.
Jiří FiedlerDepartment of Neurosurgery, Medical Faculty, Masaryk University Brno, Brno, Czech Republic.
Mattia BrancaCTU Bern, Department of Clinical Research, University of Bern, Bern, Switzerland.
Jean-Benoit RosselCTU Bern, Department of Clinical Research, University of Bern, Bern, Switzerland.
David NetukaDepartment of Neurosurgery, Faculty Military Hospital Praha, Praha, Czech Republic.
SONOBIRDIE Trial Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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

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

setting16 European centres.

participants1004 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.

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

main outcome measuresThe 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, and incidence of intracranial bleeding was the main safety endpoint.

resultsThe results favoured the sonolysis group for the primary endpoint (11 (2.2%)

conclusionSonolysis was safe for patients undergoing carotid endarterectomy and resulted in a significant reduction in the composite incidence of ischaemic stroke, transient ischaemic attack, and death within 30 days.

trial registrationClinicaltrials.gov NCT02398734.

Indexed as

Carotid StenosisEndarterectomy, CarotidUltrasonic TherapyAgedDouble-Blind MethodEuropeFemaleHumansIschemic Attack, TransientIschemic StrokeMagnetic Resonance ImagingMaleMiddle AgedTreatment Outcome

Identifiers

PMID40107675
PMCPMC11921150

What Socratic holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.