The SIBERIA study demonstrated a clear advantage of CGuard stent implantation over the existing classical stent when using a distal anti-embolic device. At the same time, there is no Level 1 evidence for a difference between the proximal and distal anti-embolic device for the CGuard stent.
Consecutive patients 45-80 years old accepted for CAS following neurological consultation and qualification for the procedure according to center's routine practice.
More than 6-month life expectancy
Suitable clinical conditions for performing DW-MRI
Written Informed consent approved by the Ethics Committee
Currently enrolled in another investigational device or drug study that has not completed the study or that clinically interferes with the current study endpoints
Recent surgical procedure within 30-days before or planned surgery within 30-days after the stenting procedure
Hepatic active disease (bilirubin> 35 mmol / l) or renal insufficiency (serum creatinine > 2.5 mg/dL or glomerular filtration rate <60 ml / min)
Recent evolving acute stroke within 30-days of study evaluation
Parallel
Emboshield NAV6™
DeviceEmbolic Protection System for Carotid Artery Revascularization ( distal - filter) + stent CGuardTM™
Mo.Ma™
DeviceEmbolic Protection System for Carotid Artery Revascularization ( proximal - occlusion) + stent CGuardTM™
determination of ischemic lesions
Postprocedural acute ischemic lesions (MRI)
MACCE
Death, stroke, and MI
Click on the lead sponsor to view all of their trials.
Meshalkin Research Institute of Pathology of Circulation
Lead sponsor
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Collaborator
Chelyabinsk Regional Clinical Hospital
Collaborator
