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

• Sponsor: University Hospital Ostrava (Other)
• Overall Status: Completed
• CT.gov ID: NCT01591005
• Collaborator: Palacky University (Other)
• Enrollment: 242
• Location: 1
• Arms: 4
• Duration (Months): 56
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Internal Carotid Artery Stenosis	Procedure: sonolysis; Procedure: endarterectomy; Procedure: carotid stenting	Phase 3

Detailed Description

AIM OF THE PROJECT AND HYPOTHESIS The aim of the project is to demonstrate an effect of continual TCD monitoring using 2 MHz diagnostic probe with maximal diagnostic energy on the reduction of risk of brain microinfarctions due to the activation of endogenous fibrinolytic system during CEA and CS. The second aim of the study is to compare the risk of brain infarction between CEA and 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 statistical significance. Patients will be randomized into 2 subgroups. Subgroup 1 will undergo a 60minute non-diagnostic TCD monitoring during CEA or CS. Subgroup 2 will undergo CEA or CS without TCD monitoring. The second aim is to compare number and volume of brain infarctions detected using MRI between CEA and CS patients.

Substudy "Risk of brain infarction after carotid endarterectomy and stenting" The aim of the prospective, randomized study was to compare 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 ICA stenoses undergoing elective CEA and CS.

PATIENTS AND METHODS 240 patients with ICA stenosis indicated for CEA or CS according to the criteria of the American Heart Association will be enrolled into the study during a 4-year period. Altogether 120 patients indicated for CEA and 120 patients indicated for CS will be randomized for standard CEA / CS and TCD monitored CEA / CS.

Randomization: Randomization using computer generated random allocation will be used, separately for CEA and CS patients.

Substudy "Risk of brain infarction after carotid endarterectomy and stenting" Minimally146 patients with ICA stenosis >70% (symptomatic or asymptomatic) detected by duplex sonography and confirmed using computed tomography angiography (CTA); indication for carotid intervention (CEA or CAS) according to criteria set by the American Heart Association5; age 40-80 years; (iv) functionally independent (modified Rankin score 0-2 points); no contraindication to magnetic resonance imaging (MRI), computer tomography angiography (CTA) or digital angiography (DSA) will be enrolled to the Substudy.

Randomization: Randomization using computer generated random allocation to CEA or CS will be used.

Sonothrombolysis: In patients randomized into sonothrombolysis subgroup, middle cerebral artery (MCA) segment in depth 55 mm will be monitored for 40 minutes using a diagnostic 2 MHz probe with maximal diagnostic energy. Non-diagnostic TCD monitoring will be performed without detection of microembolic signals or detection of changes in blood flow. The second (control) subgroup will undergo a standard CEA or CS without sonothrombolysis.

MRI protocol will consists of 4 sequences: 1. Localizer; 2. T2-weighted images (T2TSE); 3. fluid-attenuated inversion recovery (FLAIR); 4. diffusion-weighted imaging (DWI). Sequences 1-3 will be applied in the same level, they will have the same slice thickness and the same cut number. The slice thickness comprises its own cut thickness (5 mm) + distant factor (30%). Standard number of slices is 19. Standard slice level is considered to be a modified level of skull base due to the minimalization of distant artifacts echo planar imaging (EPI) sequence. Sequence called "trace" with three types of magnetic resonance pictures in every slice: (a) T2EPI b=0; (b) DWI b=500; (c) DWI b=1000. The fourth type of images automatically created an apparent diffusion coefficient (ADC) map (in-line postprocessing). DWI show a middle (average) diffusivity of every point of examined brain tissue when b value is 500 and 1000. This sequence is applied in order to assess hemorrhage (T2EPI) and monitor sites of reduced diffusion (DWI, b=500 and 1000). New infarctions will be evaluated only in the territory of treated ICA.

Adverse effects: All adverse effects during 1 month after ultrasound monitoring will be registered, especially all causes for new admissions to the hospital, worsening of neurological symptoms (>4 points in NIH stroke scale), brain edema, symptomatic and asymptomatic intracranial bleeding detected in control brain MRI.

Statistic evaluation: All statistical tests will be performed at the Department of Biophysics, Informatics and Biometry, Palacký University Medical School, Olomouc. Statistical evaluation in 5% level of significance of differences in the number and volume of brain infarctions detected using MRI between patients with TCD monitoring and without TCD monitoring during CEA or CS will be performed using Student T-test, χ2-test, Mann-Whitney U-test, ANOVA and multivariate analysis. Differences in the number and volume of brain infarctions between patients after CEA and CS will be evaluated as secondary end-points. Influence of other factors, e.g. age, gender, symptoms in the territory of treated artery, number of infarctions before CEA or CS, results of cognitive tests will be evaluated.

Statistic evaluation for Substudy: The normality of distribution of all data will be checked using the Shapiro-Wilk test. Categorical variables in the two arms will be compared by Fisher's exact test. Continuous variables will be compared by the Student's t-test for normally distributed values and by Mann-Whitney U test for other values. Multiple logistic regression analyses were used to determine the possible predictors of a new brain infarction. All tests were carried out at an alpha level of significance of 0.05.

Study protocol has been approved by the Ethics Committees in accordance with the principles and guidelines of the Declaration of Helsinki, 1975.

Study Design

• Study Type: Interventional
• Actual Enrollment: 242 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: 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
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CEA with sonolysis endarterectomy with sonolysis (continual transcranial Doppler monitoring)	Procedure: sonolysis; continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes; Other Names: sonothrombolysis sonothrombotripsy ; Procedure: endarterectomy; carotid endarterectomy; Other Names: carotid endarterectomy
Placebo Comparator: CEA without sonolysis endarterectomy without sonolysis	Procedure: endarterectomy; carotid endarterectomy; Other Names: carotid endarterectomy
Experimental: carotid stenting with sonolysis carotid stenting with sonolysis (continual transcranial Doppler monitoring)	Procedure: sonolysis; continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes; Other Names: sonothrombolysis sonothrombotripsy ; Procedure: carotid stenting; percutaneous transluminal angioplasty and stenting; Other Names: percutaneous transluminal angioplasty and stenting
Placebo Comparator: carotid stenting without sonolysis carotid stenting without sonolysis	Procedure: carotid stenting; percutaneous transluminal angioplasty and stenting; Other Names: percutaneous transluminal angioplasty and stenting

Outcome Measures

Primary Outcome Measures

1. Participants With a New Brain Infarction Detected Using Magnetic Resonance [24 hours after intervention]

   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.

Secondary Outcome Measures

1. Participants With a New Brain Infarctions Detected Using Magnetic Resonance in Endarterectomy and Stenting Groups [24 hours after intervention]

   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.

2. Cognitive Decline [24 hours after intervention]

   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.

3. Number of Participants With Clinical Manifested Brain Infarction [24 hours and 30 days after intervention]

   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.

4. Number of Participatns With New Ipsilateral Brain Infarctions Detected Using MRI in Endarterectomy and Stenting Groups [24 hours after intervention]

   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.

5. Number of Participants With Clinical Vascular Event or Death [30 days after intervention]

   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.

Other Outcome Measures

1. Number of Participants With Complications [24 hours and 30 days after intervention]

   Any complication during carotid endarterectomy and carotid stenting, sonolysis or 30 days after intervention in all subgroups.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• contraindication to MRI examination (pace-maker, implanted metal material, claustrophobia)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ostrava	Ostrava		Czech Republic	70852

Sponsors and Collaborators

• University Hospital Ostrava
• Palacky University

Investigators

• Principal Investigator: David Skoloudik, MD, PhD, University Hospital Ostrava

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• University Hospital Ostrava
• Ministry of Health of Czech Republic

Publications

None provided.

• Responsible Party: Vaclav Prochazka, MD, PhD. MSc, Vaclav Prochazka, MD, PhD, MSc, University Hospital Ostrava
• ClinicalTrials.gov Identifier: NCT01591005
• Other Study ID Numbers: NT11386-5/2010
• First Posted: May 3, 2012
• Last Update Posted: Sep 8, 2016
• Last Verified: Jul 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Vaclav Prochazka, MD, PhD. MSc, Vaclav Prochazka, MD, PhD, MSc, University Hospital Ostrava: sonolysis; carotid; endarterectomy; stenting
• Additional relevant MeSH terms: Carotid Stenosis; Brain Infarction; Infarction

Study Results

Participant Flow

Arm/Group Title	CEA With Sonolysis	CEA Without Sonolysis	Carotid Stenting With Sonolysis	Carotid Stenting Without Sonolysis
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

Baseline Characteristics

Arm/Group Title	CEA With Sonolysis	CEA Without Sonolysis	Carotid Stenting With Sonolysis	Carotid Stenting Without Sonolysis	Total
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 Participants	53	53	68	68	242
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.0 (7.3)	63.0 (7.5)	66.8 (6.7)	68.5 (7.7)	65.8 (7.6)
Sex: Female, Male (Count of 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 (participants) [Number]
Czech Republic	53 100%	53 100%	68 100%	68 100%	242 100%

Outcome Measures

1. Primary Outcome

Title	Participants With a New Brain Infarction Detected Using Magnetic Resonance
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Carotid Endarterectomy With Sonolysis	Carotid Endarterectomy Without Sonolysis	Carotid Stenting With Sonolysis	Carotid Stenting Without Sonolysis
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
Measure Participants	53	53	68	68
Number [participants]	5 9.4%	15 28.3%	33 48.5%	42 61.8%

2. Secondary Outcome

Title	Participants With a New Brain Infarctions Detected Using Magnetic Resonance in Endarterectomy and Stenting Groups
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Carotid Endarterectomy With Sonolysis	Carotid Endarterectomy Without Sonolysis	Carotid Stenting With Sonolysis	Carotid Stenting Without Sonolysis
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
Measure Participants	53	53	68	68
Number [participants]	3 5.7%	7 13.2%	3 4.4%	17 25%

3. Secondary Outcome

Title	Cognitive Decline
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

Outcome Measure Data

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
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
Measure Participants	35	37	47	46
Median (Inter-Quartile Range) [Scores on a scale]	28	27	28	27

4. Secondary Outcome

Title	Number of Participants With Clinical Manifested Brain Infarction
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Carotid Endarterectomy With Sonolysis	Carotid Endarterectomy Without Sonolysis	Carotid Stenting With Sonolysis	Carotid Stenting Without Sonolysis
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
Measure Participants	53	53	68	68
Number [participants]	1 1.9%	0 0%	0 0%	3 4.4%

5. Secondary Outcome

Title	Number of Participatns With New Ipsilateral Brain Infarctions Detected Using MRI in Endarterectomy and Stenting Groups
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Carotid Endarterectomy With Sonolysis	Carotid Endarterectomy Without Sonolysis	Carotid Stenting With Sonolysis	Carotid Stenting Without Sonolysis
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
Measure Participants	53	53	68	68
Number [participants]	5 9.4%	14 26.4%	26 38.2%	38 55.9%

6. Secondary Outcome

Title	Number of Participants With Clinical Vascular Event or Death
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Carotid Endarterectomy With Sonolysis	Carotid Endarterectomy Without Sonolysis	Carotid Stenting With Sonolysis	Carotid Stenting Without Sonolysis
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
Measure Participants	53	53	68	68
Number [participants]	0 0%	0 0%	0 0%	0 0%

7. Other Pre-specified Outcome

Title	Number of Participants With Complications
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Carotid Endarterectomy With Sonolysis	Carotid Endarterectomy Without Sonolysis	Carotid Stenting With Sonolysis	Carotid Stenting Without Sonolysis
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
Measure Participants	53	53	68	68
Number [participants]	0 0%	0 0%	0 0%	0 0%

Adverse Events

Time Frame	1 month
Arm/Group Title	CEA With Sonolysis		CEA Without Sonolysis		Carotid Stenting With Sonolysis		Carotid Stenting Without Sonolysis
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	CEA With Sonolysis		CEA Without Sonolysis		Carotid Stenting With Sonolysis		Carotid Stenting Without Sonolysis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/53 (0%)		0/68 (0%)		0/68 (0%)
Other (Not Including Serious) Adverse Events
	CEA With Sonolysis		CEA Without Sonolysis		Carotid Stenting With Sonolysis		Carotid Stenting Without Sonolysis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/53 (0%)		0/68 (0%)		0/68 (0%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.