Neuroguard Stent Shows Safety and Efficacy for Carotid Atherosclerotic Disease

Introduction The Neuroguard® 3‐in‐1 system is a nitinol carotid stent with an integrated embolic filter and post‐dilatation balloon, designed for treatment of carotid artery stenosis. This study represents the first post‐marketing evaluation of its safety and efficacy under real‐world clinical conditions. Methods This retrospective multicenter study included patients with carotid artery stenosis who underwent Neuroguard stenting across eight centers between November 2024 and August 2025. Patients with recent disabling stroke were excluded. The primary outcomes were symptomatic stroke, myocardial infarction, early neurological deterioration (END), defined as an increase of ≥4 points in NIHSS within 24 hours post‐procedure, and 30‐day periprocedural or non‐periprocedural mortality. Secondary outcomes included intraprocedural distal embolization, and intracranial hemorrhage. Results A total of 68 cases were included, with a median clinical follow‐up of 41.5 days (31, 63). Of these, 20 patients were female (29.4%), and the mean age was 71.1±9.4 years. At presentation, 51 patients (75.0%) were symptomatic, with a median symptom duration of 2 days. The median pre‐procedural NIHSS score was 1 (0‐4). The mean degree of ICA stenosis, measured by NASCET criteria, was 75.9±12.5%. Plaque length was <10 mm in 25 cases (36.8%), 10‐15 mm in 28 cases (41.2%), and >15 mm in 15 cases (22.1%). Intervention details are summarized in Table 1. Successful stent placement was achieved in 67 of 68 patients (98.5%). The single failure was due to severe extracranial ICA tortuosity, which prevented proper stent positioning. No cases of distal embolization or intraprocedural complications occurred. No symptomatic strokes or myocardial infarctions were observed among the primary outcomes. One patient (1.5%) experienced END. The 30‐day periprocedural mortality rate was 2.9% (n=2), both deaths attributable to sepsis unrelated to the stenting procedure. Two patients (2.9%) developed asymptomatic intracranial hemorrhage, with ECAS scores of HI1 and PH2, respectively. Radiographic follow‐up was available for 45 patients (35.5% with CT angiography, 64.5% with carotid Doppler), with a median follow‐up of 42 days. Among these, 36 had patent stents (80.0%), 6 demonstrated 0‐50% restenosis (13.3%), and 3 had 50‐70% in‐stent restenosis (6.7%). At the last clinical follow‐up, the median mRS was 1 (0, 2) and the median NIHSS was 0 (0, 3). Conclusion In this first post‐marketing multicenter evaluation, the Neuroguard stent demonstrated favorable 30‐day safety and efficacy in the treatment of carotid artery stenosis, comparable to contemporary trials such as CREST. Further evaluation with larger cohorts and extended follow‐up is necessary.