Phase 3
N=242
SONOlysis in Prevention of Brain Infarctions dUring Carotid Stenting and caroTid EndaRterectomy
Internal Carotid Artery Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT01591005 ↗Enrolled (actual)
242
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcome: Primary: Participants With a New Brain Infarction Detected Using Magnetic Resonance — 5; 15; 33; 42 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- sonolysis (Procedure); endarterectomy (Procedure); carotid stenting (Procedure)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University Hospital Ostrava
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With a New Brain Infarction Detected Using Magnetic Resonance |
5; 15; 33; 42 | — |
| SECONDARY Participants With a New Brain Infarctions Detected Using Magnetic Resonance in Endarterectomy and Stenting Groups |
3; 7; 3; 17 | — |
| SECONDARY Cognitive Decline |
28; 27; 28; 27 | — |
| SECONDARY Number of Participants With Clinical Manifested Brain Infarction |
1; 0; 0; 3 | — |
| SECONDARY Number of Participatns With New Ipsilateral Brain Infarctions Detected Using MRI in Endarterectomy and Stenting Groups |
5; 14; 26; 38 | — |
| SECONDARY Number of Participants With Clinical Vascular Event or Death |
0; 0; 0; 0 | — |
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)
Data sourced from ClinicalTrials.gov (NCT01591005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.