First Prospective, Single-Arm, Multicenter Study to Evaluate the Safety and Efficacy of the Overall Thrombectomy System for Stroke: iNedit, iNdeep, and iNtercept in Patients with Acute Ischemic Stroke (SEMTiC-01 Study).

BACKGROUND AND PURPOSE: Mechanical thrombectomy (MT) is the standard of care for acute ischemic stroke (AIS) due to large vessel occlusion (LVO), but the optimal combination of devices remains under investigation. The Safety and Efficacy of the Overall Thrombectomy System for Stroke (SEMTiC-01) trial evaluates the safety and efficacy of a novel, fully integrated neurothrombectomy system composed of the iNedit balloon distal access catheter, the iNdeep microcatheter, and the iNtercept stent retriever.

MATERIALS AND

METHODS

SEMTiC-01 is a prospective, multicenter, single-arm, open-label trial conducted across 18 centers in Spain, Germany, and Belgium. A total of 175 patients with LVO stroke were enrolled and treated within 24 hours of symptom onset. The primary efficacy end point was the rate of successful reperfusion (expanded Thrombolysis in Cerebral Infarction [eTICI] score ≥2b) in ≤3 passes. The primary safety end points included serious adverse events within 24 hours and 90-day mortality. Secondary end points included good functional outcome (mRS 0-2 at 90 days), early neurologic improvement, and device navigability.

RESULTS

Successful reperfusion was achieved in 75.4% of the intention-to-treat (ITT) and 83.6% of the per-protocol (PP) population. Good functional outcomes were observed in 55.8% (ITT) and 56.9% (PP), and rapid neurologic improvement in 64.6% of patients. First-pass reperfusion (eTICI ≥2b) was obtained in 46.9% (ITT) and 51.4% (PP). Symptomatic intracranial hemorrhage occurred in 1.7% (ITT), and mortality at 90 days was 13.7%. Device navigability was rated good in more than 75% of cases for both iNedit, iNtercept, and iNdeep. Balloon inflation during thrombectomy improved outcomes in M1 occlusions.

CONCLUSIONS

The triad system (iNedit, iNdeep, and iNtercept) demonstrates noninferiority compared with published literature, with favorable safety and efficacy profiles. Its favorable navigability suggests it is a promising option for MT in AIS.