Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With Distal Versus Proximal EPS

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorMeshalkin Research Institute of Pathology of Circulation

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Emboshield NAV6™
  • Mo.Ma™

Treatment groups

366 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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