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
Results First Received: December 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Internal Carotid Artery Stenosis
Interventions: Procedure: sonolysis
Procedure: endarterectomy
Procedure: carotid stenting

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
CEA With Sonolysis

endarterectomy with sonolysis (continual transcranial Doppler monitoring)

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

endarterectomy: carotid endarterectomy

CEA Without Sonolysis

endarterectomy without sonolysis

endarterectomy: carotid endarterectomy

Carotid Stenting With Sonolysis

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 without sonolysis

carotid stenting: percutaneous transluminal angioplasty and stenting


Participant Flow:   Overall Study
    CEA With Sonolysis     CEA Without Sonolysis     Carotid Stenting With Sonolysis     Carotid Stenting Without Sonolysis  
STARTED     53     53     68     68  
COMPLETED     53     53     68     68  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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

Reporting Groups
  Description
CEA With Sonolysis

endarterectomy with sonolysis (continual transcranial Doppler monitoring)

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

endarterectomy: carotid endarterectomy

CEA Without Sonolysis

endarterectomy without sonolysis

endarterectomy: carotid endarterectomy

Carotid Stenting With Sonolysis

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 without sonolysis

carotid stenting: percutaneous transluminal angioplasty and stenting

Total Total of all reporting groups

Baseline Measures
    CEA With Sonolysis     CEA Without Sonolysis     Carotid Stenting With Sonolysis     Carotid Stenting Without Sonolysis     Total  
Number of Participants  
[units: participants]
  53     53     68     68     242  
Age  
[units: years]
Mean (Standard Deviation)
  64.0  (7.3)     63.0  (7.5)     66.8  (6.7)     68.5  (7.7)     65.8  (7.6)  
Gender  
[units: participants]
         
Female     20     21     15     24     80  
Male     33     32     53     44     162  
Region of Enrollment  
[units: participants]
         
Czech Republic     53     53     68     68     242  



  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Participants With a New Brain Infarctions Detected Using Magnetic Resonance in Endarterectomy and Stenting Groups   [ Time Frame: 24 hours after intervention ]

3.  Secondary:   Cognitive Decline   [ Time Frame: 24 hours after intervention ]

4.  Secondary:   Number of Participants With Clinical Manifested Brain Infarction   [ Time Frame: 24 hours and 30 days after intervention ]

5.  Secondary:   Number of Participatns With New Ipsilateral Brain Infarctions Detected Using MRI in Endarterectomy and Stenting Groups   [ Time Frame: 24 hours after intervention ]

6.  Secondary:   Number of Participants With Clinical Vascular Event or Death   [ Time Frame: 30 days after intervention ]

7.  Other Pre-specified:   Number of Participants With Complications   [ Time Frame: 24 hours and 30 days after intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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
  Hide More Information

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
e-mail: skoloudik@hotmail.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: 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