Interim SIBERIA Data Evaluate InspireMD's CGuard EPS MicroNet Carotid Stent
January 24, 2019—InspireMD, Inc. announced that interim findings from the investigator-initiated SIBERIA trial of the company's CGuard embolic prevention system (EPS) were presented at LINC, the Leipzig Interventional Course held January 22–25 in Leipzig Germany.
The SIBERIA trial is comparing InspireMD's CGuard EPS MicroNet covered stent versus the Acculink carotid stent (Abbott Vascular) in 100 consecutive randomized (1:1) patients with symptomatic and asymptomatic carotid artery disease. The primary endpoints are the incidence and volume of new lesions within the brain after carotid stenting using diffusion-weighted MRI periprocedurally and at 30 days.
At LINC, the interim data from the first 50 patients in the SIBERIA trial were presented by Andrey A. Karpenko, MD, and P. Ignatenko, MD, with the Siberian Federal Biomedical Research Center in Novosibirsk, Russia.
At the protocol-mandated 1-month interim analysis, patients in the CGuard group (who had higher risk factors) versus patients in the Acculink group had a significantly lower incidence of multiple lesions in the brain (16% vs 44%), as well as lower incidences of large cerebral lesions (24% vs 40%) and major adverse clinical events (0% vs 12%).
In the company's announcement, Dr. Karpenko commented, “We are excited that despite the higher-risk patient profile in the CGuard group, the interim results show a significant reduction of cerebral embolization while patient outcomes suggest a clinically relevant benefit of the CGuard EPS. This mandated interim analysis gives us confidence to continue enrolling patients in this trial and extending the dataset in this potentially important advancement in the stroke prevention field.”