Study overview
RecruitingThe SIBERIA II Trial
Independent Randomized Clinical Trial in Carotid Revascularization with MicroNet Covered Stent (CGuard) Comparing Early Neurological Outcomes with distal EPS Versus Proximal EPS. The SIBERIA II Trial
Study narrative
Clinical and operational context.
Description of the study: Multicenter Randomized clinical trial with two intervention arms. 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.
The main objective of this randomized control Study is to compare distal EPS versus proximal EPS in the incidence of New DW-MRI lesions post-procedural 24-48h and Death, Stroke, and Myocardial Infarction (DSMI) at Procedural, 48h, and 30 days