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SONOlysis in Prevention of Brain Infarctions dUring Carotid Stenting and caroTid EndaRterectomy (SONOBUSTER)

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ClinicalTrials.gov Identifier: NCT01591005
Recruitment Status : Completed
First Posted : May 3, 2012
Results First Posted : September 8, 2016
Last Update Posted : September 8, 2016
Sponsor:
Collaborator:
Palacky University
Information provided by (Responsible Party):
Vaclav Prochazka, MD, PhD. MSc, University Hospital Ostrava

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Internal Carotid Artery Stenosis
Interventions Procedure: sonolysis
Procedure: endarterectomy
Procedure: carotid stenting
Enrollment 242

Recruitment Details  
Pre-assignment Details  
Arm/Group Title CEA With Sonolysis CEA Without Sonolysis Carotid Stenting With Sonolysis Carotid Stenting Without Sonolysis
Hide Arm/Group Description

endarterectomy with sonolysis (continual transcranial Doppler monitoring)

sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes

endarterectomy: carotid endarterectomy

endarterectomy without sonolysis

endarterectomy: carotid endarterectomy

carotid stenting with sonolysis (continual transcranial Doppler monitoring)

sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes

carotid stenting: percutaneous transluminal angioplasty and stenting

carotid stenting without sonolysis

carotid stenting: percutaneous transluminal angioplasty and stenting

Period Title: Overall Study
Started 53 53 68 68
Completed 53 53 68 68
Not Completed 0 0 0 0
Arm/Group Title CEA With Sonolysis CEA Without Sonolysis Carotid Stenting With Sonolysis Carotid Stenting Without Sonolysis Total
Hide Arm/Group Description

endarterectomy with sonolysis (continual transcranial Doppler monitoring)

sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes

endarterectomy: carotid endarterectomy

endarterectomy without sonolysis

endarterectomy: carotid endarterectomy

carotid stenting with sonolysis (continual transcranial Doppler monitoring)

sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes

carotid stenting: percutaneous transluminal angioplasty and stenting

carotid stenting without sonolysis

carotid stenting: percutaneous transluminal angioplasty and stenting

Total of all reporting groups
Overall Number of Baseline Participants 53 53 68 68 242
Hide Baseline Analysis Population Description
In total, 242 of the 495 screened patients fulfilled the inclusion criteria. Subjects were randomly and equally allocated to the sonolysis or control group. Clinical and procedural variables were well balanced between the groups
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 53 participants 68 participants 68 participants 242 participants
64.0  (7.3) 63.0  (7.5) 66.8  (6.7) 68.5  (7.7) 65.8  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 53 participants 68 participants 68 participants 242 participants
Female
20
  37.7%
21
  39.6%
15
  22.1%
24
  35.3%
80
  33.1%
Male
33
  62.3%
32
  60.4%
53
  77.9%
44
  64.7%
162
  66.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Czech Republic Number Analyzed 53 participants 53 participants 68 participants 68 participants 242 participants
53 53 68 68 242
1.Primary Outcome
Title Participants With a New Brain Infarction Detected Using Magnetic Resonance
Hide Description

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.

Time Frame 24 hours after intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carotid Endarterectomy With Sonolysis Carotid Endarterectomy Without Sonolysis Carotid Stenting With Sonolysis Carotid Stenting Without Sonolysis
Hide Arm/Group Description:

endarterectomy with sonolysis (continual transcranial Doppler monitoring)

sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes

endarterectomy: carotid endarterectomy

endarterectomy without sonolysis

endarterectomy: carotid endarterectomy

carotid stenting with sonolysis (continual transcranial Doppler monitoring)

sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes

carotid stenting: percutaneous transluminal angioplasty and stenting

carotid stenting without sonolysis

carotid stenting: percutaneous transluminal angioplasty and stenting

Overall Number of Participants Analyzed 53 53 68 68
Measure Type: Number
Unit of Measure: participants
5 15 33 42
2.Secondary Outcome
Title Participants With a New Brain Infarctions Detected Using Magnetic Resonance in Endarterectomy and Stenting Groups
Hide Description

The number of participants with a new brain infarctions >0.5 cm3 detected using magnetic resonance examination 24 hours after intervention between endarterectomy and stenting using periprocedural sonolysis.

Substudy: The number of participants with a new brain infarctions >0.5 cm3 detected using magnetic resonance examination 24 hours after intervention between carotid endarterectomy and carotid stenting groups.

Time Frame 24 hours after intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carotid Endarterectomy With Sonolysis Carotid Endarterectomy Without Sonolysis Carotid Stenting With Sonolysis Carotid Stenting Without Sonolysis
Hide Arm/Group Description:

endarterectomy with sonolysis (continual transcranial Doppler monitoring)

sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes

endarterectomy: carotid endarterectomy

endarterectomy without sonolysis

endarterectomy: carotid endarterectomy

carotid stenting with sonolysis (continual transcranial Doppler monitoring)

sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes

carotid stenting: percutaneous transluminal angioplasty and stenting

carotid stenting without sonolysis

carotid stenting: percutaneous transluminal angioplasty and stenting

Overall Number of Participants Analyzed 53 53 68 68
Measure Type: Number
Unit of Measure: participants
3 7 3 17
3.Secondary Outcome
Title Cognitive Decline
Hide Description

The changes in cognitive functions after carotid endarterectomy and carotid stenting measured by Mini-Mental State Examination using periprocedural sonolysis.

Substudy: The changes in cognitive functions after intervention measured by Mini-Mental State Examination between carotid endarterectomy and carotid stenting groups.

Range of scores possible for the Mini-Mental State Examination: 0 - 30 points. Higher values in this range are considered to be a better outcome.

Time Frame 24 hours after intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
only patients with performed Mini Mental State examination
Arm/Group Title Carotid Endarterectomy With Sonolysis Carotid Endarterectomy Without Sonolysis Carotid Stenting With Sonolysis Carotid Stenting Without Sonolysis
Hide Arm/Group Description:

endarterectomy with sonolysis (continual transcranial Doppler monitoring)

sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes

endarterectomy: carotid endarterectomy

endarterectomy without sonolysis

endarterectomy: carotid endarterectomy

carotid stenting with sonolysis (continual transcranial Doppler monitoring)

sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes

carotid stenting: percutaneous transluminal angioplasty and stenting

carotid stenting without sonolysis

carotid stenting: percutaneous transluminal angioplasty and stenting

Overall Number of Participants Analyzed 35 37 47 46
Median (Inter-Quartile Range)
Unit of Measure: Scores on a scale
28
(26 to 29)
27
(25 to 28)
28
(26 to 29)
27
(25 to 29)
4.Secondary Outcome
Title Number of Participants With Clinical Manifested Brain Infarction
Hide Description

The risk of stroke or transient ischemic attack (at 24 hours and 30 days) due to the activation of endogenous fibrinolytic system during carotid endarterectomy and carotid stenting using periprocedural sonolysis.

Substudy: The risk of stroke or transient ischemic attack (at 24 hours and 30 days) due to the activation of endogenous fibrinolytic system between carotid endarterectomy and carotid stenting groups.

Time Frame 24 hours and 30 days after intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carotid Endarterectomy With Sonolysis Carotid Endarterectomy Without Sonolysis Carotid Stenting With Sonolysis Carotid Stenting Without Sonolysis
Hide Arm/Group Description:

endarterectomy with sonolysis (continual transcranial Doppler monitoring)

sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes

endarterectomy: carotid endarterectomy

endarterectomy without sonolysis

endarterectomy: carotid endarterectomy

carotid stenting with sonolysis (continual transcranial Doppler monitoring)

sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes

carotid stenting: percutaneous transluminal angioplasty and stenting

carotid stenting without sonolysis

carotid stenting: percutaneous transluminal angioplasty and stenting

Overall Number of Participants Analyzed 53 53 68 68
Measure Type: Number
Unit of Measure: participants
1 0 0 3
5.Secondary Outcome
Title Number of Participatns With New Ipsilateral Brain Infarctions Detected Using MRI in Endarterectomy and Stenting Groups
Hide Description

The number of patients with the ipsilateral brain infarctions detected using MRI examination 24 hours after intervention between endarterectomy and stenting using periprocedural sonolysis.

Substudy: The number of patients with the ipsilateral brain infarctions detected using MRI examination 24 hours after intervention between carotid endarterectomy and carotid stenting groups.

Time Frame 24 hours after intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carotid Endarterectomy With Sonolysis Carotid Endarterectomy Without Sonolysis Carotid Stenting With Sonolysis Carotid Stenting Without Sonolysis
Hide Arm/Group Description:

endarterectomy with sonolysis (continual transcranial Doppler monitoring)

sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes

endarterectomy: carotid endarterectomy

endarterectomy without sonolysis

endarterectomy: carotid endarterectomy

carotid stenting with sonolysis (continual transcranial Doppler monitoring)

sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes

carotid stenting: percutaneous transluminal angioplasty and stenting

carotid stenting without sonolysis

carotid stenting: percutaneous transluminal angioplasty and stenting

Overall Number of Participants Analyzed 53 53 68 68
Measure Type: Number
Unit of Measure: participants
5 14 26 38
6.Secondary Outcome
Title Number of Participants With Clinical Vascular Event or Death
Hide Description

The risk of the occurrence of death, any stroke, or myocardial infarction within 30 days (myocardial infarction was defined as a post-interventional cardiac troponin T level increase >2-fold the upper limit of normal in addition to either chest pain or symptoms consistent with ischemia or electrocardiographic evidence of ischemia) after carotid endarterectomy and carotid stenting using periprocedural sonolysis.

Substudy: The risk of the occurrence of death, any stroke, or myocardial infarction within 30 days (myocardial infarction was defined as a post-interventional cardiac troponin T level increase >2-fold the upper limit of normal in addition to either chest pain or symptoms consistent with ischemia or electrocardiographic evidence of ischemia) between carotid endarterectomy and carotid stenting groups.

Time Frame 30 days after intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carotid Endarterectomy With Sonolysis Carotid Endarterectomy Without Sonolysis Carotid Stenting With Sonolysis Carotid Stenting Without Sonolysis
Hide Arm/Group Description:

endarterectomy with sonolysis (continual transcranial Doppler monitoring)

sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes

endarterectomy: carotid endarterectomy

endarterectomy without sonolysis

endarterectomy: carotid endarterectomy

carotid stenting with sonolysis (continual transcranial Doppler monitoring)

sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes

carotid stenting: percutaneous transluminal angioplasty and stenting

carotid stenting without sonolysis

carotid stenting: percutaneous transluminal angioplasty and stenting

Overall Number of Participants Analyzed 53 53 68 68
Measure Type: Number
Unit of Measure: participants
0 0 0 0
7.Other Pre-specified Outcome
Title Number of Participants With Complications
Hide Description Any complication during carotid endarterectomy and carotid stenting, sonolysis or 30 days after intervention in all subgroups.
Time Frame 24 hours and 30 days after intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carotid Endarterectomy With Sonolysis Carotid Endarterectomy Without Sonolysis Carotid Stenting With Sonolysis Carotid Stenting Without Sonolysis
Hide Arm/Group Description:

endarterectomy with sonolysis (continual transcranial Doppler monitoring)

sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes

endarterectomy: carotid endarterectomy

endarterectomy without sonolysis

endarterectomy: carotid endarterectomy

carotid stenting with sonolysis (continual transcranial Doppler monitoring)

sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes

carotid stenting: percutaneous transluminal angioplasty and stenting

carotid stenting without sonolysis

carotid stenting: percutaneous transluminal angioplasty and stenting

Overall Number of Participants Analyzed 53 53 68 68
Measure Type: Number
Unit of Measure: participants
0 0 0 0
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CEA With Sonolysis CEA Without Sonolysis Carotid Stenting With Sonolysis Carotid Stenting Without Sonolysis
Hide Arm/Group Description

endarterectomy with sonolysis (continual transcranial Doppler monitoring)

sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes

endarterectomy: carotid endarterectomy

endarterectomy without sonolysis

endarterectomy: carotid endarterectomy

carotid stenting with sonolysis (continual transcranial Doppler monitoring)

sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes

carotid stenting: percutaneous transluminal angioplasty and stenting

carotid stenting without sonolysis

carotid stenting: percutaneous transluminal angioplasty and stenting

All-Cause Mortality
CEA With Sonolysis CEA Without Sonolysis Carotid Stenting With Sonolysis Carotid Stenting Without Sonolysis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CEA With Sonolysis CEA Without Sonolysis Carotid Stenting With Sonolysis Carotid Stenting Without Sonolysis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   0/53 (0.00%)   0/68 (0.00%)   0/68 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CEA With Sonolysis CEA Without Sonolysis Carotid Stenting With Sonolysis Carotid Stenting Without Sonolysis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   0/53 (0.00%)   0/68 (0.00%)   0/68 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Prof. David Skoloudik, MD, Ph.D.
Organization: University Hospital Ostrava
Phone: +420597375613
Responsible Party: Vaclav Prochazka, MD, PhD. MSc, University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT01591005     History of Changes
Other Study ID Numbers: NT11386-5/2010
First Submitted: April 23, 2012
First Posted: May 3, 2012
Results First Submitted: December 22, 2015
Results First Posted: September 8, 2016
Last Update Posted: September 8, 2016