Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborator:
Palacky University
Information provided by (Responsible Party):
Vaclav Prochazka, MD, PhD. MSc, University Hospital Ostrava
ClinicalTrials.gov Identifier:
NCT01591005
First received: April 23, 2012
Last updated: July 24, 2016
Last verified: July 2016
  Purpose

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 Intervention Phase
Internal Carotid Artery Stenosis
Procedure: sonolysis
Procedure: endarterectomy
Procedure: carotid stenting
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Further study details as provided by University Hospital Ostrava:

Primary Outcome Measures:
  • Participants With a New Brain Infarction Detected Using Magnetic Resonance [ Time Frame: 24 hours after intervention ] [ Designated as safety issue: Yes ]

    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:
  • Participants With a New Brain Infarctions Detected Using Magnetic Resonance in Endarterectomy and Stenting Groups [ Time Frame: 24 hours after intervention ] [ Designated as safety issue: No ]

    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.


  • Cognitive Decline [ Time Frame: 24 hours after intervention ] [ Designated as safety issue: No ]

    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.


  • Number of Participants With Clinical Manifested Brain Infarction [ Time Frame: 24 hours and 30 days after intervention ] [ Designated as safety issue: Yes ]

    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.


  • Number of Participatns With New Ipsilateral Brain Infarctions Detected Using MRI in Endarterectomy and Stenting Groups [ Time Frame: 24 hours after intervention ] [ Designated as safety issue: No ]

    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.


  • Number of Participants With Clinical Vascular Event or Death [ Time Frame: 30 days after intervention ] [ Designated as safety issue: Yes ]

    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:
  • Number of Participants With Complications [ Time Frame: 24 hours and 30 days after intervention ] [ Designated as safety issue: Yes ]
    Any complication during carotid endarterectomy and carotid stenting, sonolysis or 30 days after intervention in all subgroups.


Enrollment: 242
Study Start Date: October 2010
Study Completion Date: June 2015
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: carotid endarterectomy
Placebo Comparator: CEA without sonolysis
endarterectomy without sonolysis
Procedure: endarterectomy
carotid endarterectomy
Other Name: 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 Name: percutaneous transluminal angioplasty and stenting
Placebo Comparator: carotid stenting without sonolysis
carotid stenting without sonolysis
Procedure: carotid stenting
percutaneous transluminal angioplasty and stenting
Other Name: percutaneous transluminal angioplasty and stenting

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591005

Locations
Czech Republic
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
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vaclav Prochazka, MD, PhD. MSc, Vaclav Prochazka, MD, PhD, MSc, University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT01591005     History of Changes
Other Study ID Numbers: NT11386-5/2010 
Study First Received: April 23, 2012
Results First Received: December 22, 2015
Last Updated: July 24, 2016
Health Authority: Czech Republic: Ethics Committee
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by University Hospital Ostrava:
sonolysis
carotid
endarterectomy
stenting

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Infarction
Brain Infarction
Ischemia
Pathologic Processes
Necrosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia
Stroke

ClinicalTrials.gov processed this record on September 30, 2016