Introduction The iVascular neurothrombectomy devices, which include a balloon distal access catheter (iNedit), a microcatheter (iNdeep), and a stent retriever (iNtercept), have been strategically designed to incorporate the benefits of temporary proximal blood flow restriction via a balloon situated 5 cm from the catheter tip. This setup, paired with a guiding distal access catheter, facilitates clot removal through the combined action of a stent retriever and distal aspiration.

Aim of Study To assess the efficacy and safety of three devices (iNedit, iNdeep, and iNtercept) in mechanical thrombectomy for patients with acute ischemic stroke due to large vessel occlusion, presented within 24 hours from symptoms onset.

Methods SEMTIC is a prospective, single-arm, multi-center study with blinded outcomes assessment. Efficacy endpoints: successful reperfusion (eTICI≥2b) within three passes and mRS 0-2 at 90 days. Safety endpoints: all-cause mortality at 90 days, symptomatic intracranial hemorrhage, and embolization in a new territory.

Results A total of 115 patients participated (mean age: 73.7 ± 10.5 years; 53.9% female). Successful reperfusion was 80% (95% CI: 72% to 86%) surpassing non-inferiority proportion reported in literature. Good functional outcomes (mRS 0-2): 56% (46%, 65%). All-cause 90-day mortality: 13.9% (95% CI: 8.2% to 21.6%). Symptomatic intracranial hemorrhage: 1.7% (95% CI: 0.5% to 6.1%). Embolization in a new territory: 5.2% (95% CI: 2.1% to 11.1%).

Conclusion The combination of three iVascular devices proved to be highly effective in mechanical thrombectomy, demonstrating non-inferiority in successful reperfusion parameters with no safety concerns.

Disclosure of Interest no.