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A Novel Carotid Artery Stent System Integrating Balloon, Stent, and Embolic Protection Device Retrieval Catheter

shen, s.; Li, S.; Liu, T.; Zhang, C.; Duan, H.

2025-12-11 neurology
10.64898/2025.12.04.25341672 medRxiv
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BackgroundCarotid artery stenosis is a common cause of ischemic stroke, and carotid artery stenting is an important treatment for carotid artery stenosis. However, current carotid stents face issues such as cumbersome operation procedures and frequent difficulties in retrieving embolic protection devices which can lead to complications. ObjectivesThis study evaluated the safety and efficacy of a novel carotid artery stent system which integrates balloon, stent and embolic protection device retrieval catheter. MethodsA total of ten Bama miniature pigs were used to establish carotid artery stenosis models. Angiography, optical coherence tomography (OCT) and Doppler ultrasound were performed to assess the degree of stenosis improvement and in-stent restenosis. HE staining was utilized to detect intimal hyperplasia. ResultsAll stent implantation procedures were successful in 10 pigs. The stenosis degree was significantly improved immediately after stent implantation with residual stenosis <5% and follow-up exams at 5 months postoperatively showed no significant in-stent restenosis and intimal hyperplasia. ConclusionsThe novel carotid artery stent system appears safe and can effectively improve the stenosis degree of the carotid artery.

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