SONOlysis in Prevention of Brain Infarctions dUring Carotid Stenting and caroTid EndaRterectomy
Condition: Internal Carotid Artery Stenosis
MeSH terms: Carotid Stenosis; Brain Infarction; Infarction
Intervention: sonolysis; endarterectomy; carotid stenting
Intervention description: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes; carotid endarterectomy; percutaneous transluminal angioplasty and stenting
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 242.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: sonolysis; carotid; endarterectomy; stenting

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.
    

Eligibility 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)