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Study overview

Recruiting

The 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

The SIBERIA II Trial study artwork

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