First prospective, single-arm, multicenter study to evaluate safety and efficacy of the overall thrombectomy system -iNedit, iNdeep, and iNtercept- for acute ischemic stroke. Rationale beyond the study

TL;DR

This study is the first to evaluate a new combined thrombectomy system for treating acute ischemic stroke, focusing on its safety and effectiveness.

Contribution

The study introduces and evaluates a novel integrated thrombectomy system combining iNedit, iNdeep, and iNtercept in a single procedure.

Findings

The study is designed to assess the efficacy endpoint of eTICI ≥2b revascularization within three stent retriever passes.

Safety is evaluated by monitoring serious adverse events and 90-day mortality.

The study uses a sequential design with interim and final analyses to ensure statistical power.

Abstract

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 [Safety and Efficacy of the overall throMbectomy system for sTroke (SEMTiC) strategy], has not been tested.

The 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.

The 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.

SEMTiC-01 is a prospective, multicenter, single-arm, open-label clinical safety and efficacy investigation.

Primary efficacy endpoint: expanded treatment in cerebral infarction score (eTICI) ≥2b revascularization within ≤ 3 stent retriever passes. Primary safety endpoint: monitoring serious adverse events within 24 h post-intervention and all-cause mortality at 90 days.