First prospective, single-arm, multicenter study to evaluate Safety and Efficacy of the overall thrombectomy system for stroke: iNedit, iNdeep, iNtercept in patients with acute ischemic stroke: Rationale Beyond The Study

Luis San Roman ¹ Laura Ludovica Gramegna ² Sara Pich ³ Laura Domingo-Rodriguez ³ Marta Duran ³ Lluís Duocastella ⁴ Juan Macho ^1*

• ¹ Department of Neuroradiology, Hospital Clinic, Barcelona, Spain
• ² Vall d'Hebron Research Institute (VHIR), Barcelona, Spain
• ³ Clinical Affairs Department, iVascular, Sant Vicenç dels Horts, Spain
• ⁴ Clinal R&D Department, iVascular, Sant Vicenç dels Horts, Spain

Rationale The clinical impact of a novel mechanical thrombectomy strategy, which integrates distal access with flow reversal and flow arrest via a distal balloon, all within a single procedure, (SEMTiC strategy) has not been tested.AimThe SEMTiC-01 study is the first prospective, multicenter in vivo study evaluating the safety and efficacy of the combined thrombectomy system—iNedit, iNdeep, and iNtercept—in patients with acute ischemic stroke.Sample size estimatesThe study was designed with a sequential structure based on the efficacy endpoint (eTICI ≥2b) reported in the literature (71.1% with a 95% confidence interval of [68.5%, 73.8%]). An interim analysis was set for 115 patients and a final analysis for 225 patients, ensuring 98% power at a one-sided 0.025 significance level, with a 2.6% non-inferiority margin and a 15% assumed withdrawal rate.DesignProspective, multicenter, single-arm, open-label clinical safety and efficacy investigation.OutcomePrimary efficacy endpoint: eTICI ≥2b revascularization within ≤3 stent retriever passes. Primary safety endpoint: monitoring serious adverse events within 24 hours post-intervention and all-cause mortality at 90 days.