The 100-patient trial is designed to compare the two devices in terms of neuroprotection and clinical superiority in subjects undergoing carotid endarterectomy, the Tel Aviv-based company said. Conducted at the Scientific Research Institute of Circulation Pathology in Novosibirsk, the study is led by Dr. Andrei Karpenko.
The primary endpoint is new ischemic areas in the brain 24 to 48 hours post-procedure and new lesion permanence at 30 days, with clinical and ultrasound follow-up after one year.
“Having been aware of the very impressive data supporting the use of CGuard EPS for the treatment of carotid artery stenosis, we are excited to now have the opportunity to evaluate this system versus Abbott’s Rx Acculink, which is widely used in Russia today,” Karpenko said in prepared remarks.
“We are honored that Professor Karpenko and his team have elected to study CGuard EPS in this vascular surgeon-led clinical trial at the Center of Vascular & Hybrid Surgery within the Scientific Research Institute of Cardiovascular Pathology in Novosibirsk. We understand the first patients have been enrolled and treated in the trial and we look forward to the results at the conclusion of the trial. Once again, we believe that this trial will reinforce our current CGuard clinical data, and continue to validate the growing interest and support in CGuard across all clinical specialties treating carotid artery disease,” added InspireMD CEO James Barry.