SONOlysis in Prevention of Brain Infarctions dUring Carotid Stenting and caroTid EndaRterectomy
SONOBUSTER
Risk Reduction of Symptomatic and Silent Brain Infarctions During Carotid Endarterectomy and Carotid Stenting Due to Ultrasound Activation of Endogenous Fibrinolytic System Using Transcranial Doppler Monitoring
1 other identifier
interventional
242
1 country
1
Brief Summary
The aim of the project is to demonstrate a fibrinolytic effect of sonothrombolysis (continual transcranial Doppler monitoring) using 2 MegaHertz (MHz) diagnostic probe on the reduction of risk of brain infarctions due to the activation of endogenous fibrinolytic system during carotid endarterectomy (CEA) and carotid stenting (CS). 240 patients indicated for CEA (120 patients) and CS (120 patients) will be enrolled into the study in order to demonstrate a twenty-percent risk reduction of number and volume of brain infarctions detected using MRI examination 24 hours after CEA or CS in 5% level of significance. Patients will be randomized - subgroup 1 will undergo a 60minute non-diagnostic transcranial Doppler (TCD) monitoring during CEA or CS, subgroup 2 will undergo interventions without TCD monitoring. The second aim is to compare number of brain infarctions detected using MRI between CEA and CS patients. Confirmation of the investigators hypothesis that sonothrombolysis is able to activate endogenous fibrinolytic system during CEA or CS with consecutive reduction of the number and volume of brain infarcts, can lead to the increase of the safety of CEA and CS in patients with internal carotid artery stenosis. The investigators can presume that up to 50% of patients indicated for CEA or CS can be treated using these methods in the future. In the Substudy "Risk of brain infarction after carotid endarterectomy and stenting" the the risk of asymptomatic and symptomatic brain infarctions, changes in cognitive functions, as well as morbidity and mortality at 30 days between patients with symptomatic and asymptomatic severe internal carotid artery (ICA) stenoses undergoing elective CEA and CAS will be compared. The sample size of the Substudy was based on an expected 80% difference of new ischemic lesions on DWI-MRI between CEA (estimated prevalence, 30%) and CAS (54%). Pre-study calculations showed that a minimum of 73 patients in each group was needed to reach a significant difference with an alpha value of 0.05 (two-tailed) and a beta value of 0.8 assuming that 15% of subjects would be lost to follow-up or refuse to participate in the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2010
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 23, 2012
CompletedFirst Posted
Study publicly available on registry
May 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
September 8, 2016
CompletedSeptember 8, 2016
July 1, 2016
3.8 years
April 23, 2012
December 22, 2015
July 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participants With a New Brain Infarction Detected Using Magnetic Resonance
The number of participants with a new brain infarctions in sonolysis group detected using magnetic resonance examination 24 hours after carotid endarterectomy or carotid stenting. Substudy: The number of participants with a new brain infarctions on brain diffusion-weighted magnetic resonance imaging performed 24 hours after intervention in carotid endarterectomy and carotid stenting groups.
24 hours after intervention
Secondary Outcomes (5)
Participants With a New Brain Infarctions Detected Using Magnetic Resonance in Endarterectomy and Stenting Groups
24 hours after intervention
Cognitive Decline
24 hours after intervention
Number of Participants With Clinical Manifested Brain Infarction
24 hours and 30 days after intervention
Number of Participatns With New Ipsilateral Brain Infarctions Detected Using MRI in Endarterectomy and Stenting Groups
24 hours after intervention
Number of Participants With Clinical Vascular Event or Death
30 days after intervention
Other Outcomes (1)
Number of Participants With Complications
24 hours and 30 days after intervention
Study Arms (4)
CEA with sonolysis
EXPERIMENTALendarterectomy with sonolysis (continual transcranial Doppler monitoring)
CEA without sonolysis
PLACEBO COMPARATORendarterectomy without sonolysis
carotid stenting with sonolysis
EXPERIMENTALcarotid stenting with sonolysis (continual transcranial Doppler monitoring)
carotid stenting without sonolysis
PLACEBO COMPARATORcarotid stenting without sonolysis
Interventions
continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
carotid endarterectomy
percutaneous transluminal angioplasty and stenting
Eligibility Criteria
You may qualify if:
- stenosis of internal carotid artery
- indication to endarterectomy or stenting
- age 40-80 years
- sufficient temporal bone window for TCD with detectable blood flow in MCA
- independent patient (modified Rankin score 0-2)
- informed consent signed by the patient.
You may not qualify if:
- contraindication to MRI examination (pace-maker, implanted metal material, claustrophobia)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Ostravalead
- Palacky Universitycollaborator
Study Sites (1)
University Hospital Ostrava
Ostrava, Czech Republic, 70852, Czechia
Related Publications (2)
Skoloudik D, Kuliha M, Hrbac T, Jonszta T, Herzig R; SONOBUSTER Trial Group. Sonolysis in Prevention of Brain Infarction During Carotid Endarterectomy and Stenting (SONOBUSTER): a randomized, controlled trial. Eur Heart J. 2016 Oct 21;37(40):3096-3102. doi: 10.1093/eurheartj/ehv492. Epub 2015 Sep 28.
PMID: 26417059DERIVEDKuliha M, Roubec M, Prochazka V, Jonszta T, Hrbac T, Havelka J, Goldirova A, Langova K, Herzig R, Skoloudik D. Randomized clinical trial comparing neurological outcomes after carotid endarterectomy or stenting. Br J Surg. 2015 Feb;102(3):194-201. doi: 10.1002/bjs.9677. Epub 2014 Dec 16.
PMID: 25511816DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Serial follow-up MRI was not done. A software package for mapping of brain infarction volume was not used. Single-centre investigation with mandatory use of brain protection device during carotid stenting and shunt during carotid endarterectomy.
Results Point of Contact
- Title
- Prof. David Skoloudik, MD, Ph.D.
- Organization
- University Hospital Ostrava
Study Officials
- PRINCIPAL INVESTIGATOR
David Skoloudik, MD, PhD
University Hospital Ostrava
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vaclav Prochazka, MD, PhD, MSc
Study Record Dates
First Submitted
April 23, 2012
First Posted
May 3, 2012
Study Start
October 1, 2010
Primary Completion
July 1, 2014
Study Completion
June 1, 2015
Last Updated
September 8, 2016
Results First Posted
September 8, 2016
Record last verified: 2016-07