Eight-year single- center experience with double-layer carotid stent

IF 3.9 2区医学 Q1 PERIPHERAL VASCULAR DISEASE

Journal of Vascular Surgery Pub Date : 2026-03-01 Epub Date: 2025-11-28 DOI:10.1016/j.jvs.2025.11.027

Gianbattista Parlani MD , Giacomo Isernia MD, PhD , Lydia Romano MD , Francesco Pio Del Mastro MD , Piergiorgio Cao MD, FRCS , Massimo Lenti MD, PhD , Gioele Simonte MD, PhD

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引用次数: 0

Abstract

Objective

The aim of this study was to provide perioperative and mid-term evaluation, safety, and efficacy of CGuard (InspireMD) micromesh self-expanding stent with an embolic protection system during a carotid artery stenting (CAS) procedure.

Methods

All patients who underwent CAS with CGuard stent from January 2016 to June 2024 in a tertiary center were prospectively evaluated. The primary end points were technical success, combined risk of any stroke or death within 30 days (perioperative), and any ipsilateral stroke after the procedure. Secondary end points were stroke, death, transient ischemic attack, myocardial infarction (major adverse event), occurring within 30 days and the rate of stroke, death, and restenosis during the follow-up.

Results

A total of 218 consecutive patients underwent 226 CAS procedures with the CGuard stent during the study period. There were 142 male (63%) and mean age was 74.3 ± 8.0 years. Fifty-nine patients (26%) had a symptomatic stenosis. Technical success was 99.5%, because in 1 patient advancing the CGuard stent in a tight stenosis was impossible despite predilation. The mean procedural time was 33 minutes, the mean fluoroscopic time was 11 minutes, and the mean contrast media used was 41 mL. At 30 day, one patient had a transient ischemic attack (0.5%) and another patient experienced a minor stroke (0.5%). No patient died or developed myocardial infarction. The mean hospitalization duration after the procedure was 1.5 days. The 30-day rate of major adverse event was 0.5%. During a mean follow-up 35 months (range, 1-84 months), one patient had an asymptomatic stent occlusion and two patients experienced restenosis >70% successfully treated with a secondary stenting procedure in one case and stent explantation with Dacron patch closure in the other. The estimate of freedom from restenosis was 99.4% at 1 year, 97.5% at 3 years, and 97.5% at 5 years. Freedom from ipsilateral stroke was estimated 99.6% at 1 year, 98.7% at 3 years, and 98.7% at 5 years. The actuarial survival rate was 97.4% at 1 year, 92.4% at 3 years, and 78.7% at 5 years.

Conclusions

Preliminary data suggest that the CGuard stent with embolic protection system is an effective and safe device for the treatment of carotid artery stenosis with acceptably low perioperative and mid-term neurological event and durable patency rate. Larger, multicenter, randomized studies are advocated to confirm these findings.

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八年单中心双层颈动脉支架治疗经验。

目的：本研究的目的是在颈动脉支架置入（CAS）过程中对CGuard （InspireMD, Tel Aviv, Israel）微孔自膨胀支架（EPS）进行围手术期和中期评估、安全性和有效性。方法：2016年1月至2024年6月在三级中心接受颈动脉支架置入（CAS）的所有患者进行前瞻性评估。主要终点为技术成功、30天内卒中或死亡的综合风险（围手术期）以及术后同侧卒中。次要终点为30天内发生的卒中、死亡、短暂性脑缺血发作（TIA）、心肌梗死（主要不良事件或MAE）以及随访期间卒中、死亡和再狭窄的发生率。结果：在研究期间，共有218例连续患者接受了226例使用C Guard支架的CAS手术。男性142例（63%），平均年龄74.3（+ 8）岁。59例（26%）有症状性狭窄。技术上的成功率为99.5%，在一名患者中，尽管预扩张导致狭窄，但仍无法推进C保护支架。平均手术时间33分钟，平均荧光时间11分钟，平均使用造影剂41毫升。30天，1例患者发生短暂性脑缺血发作（0.5%），1例患者发生轻度脑卒中（0.5%）。无患者死亡或发生心肌梗死。术后平均住院时间为1.5天。30天MAE利率为0.5%。在平均随访35个月（1-84个月）期间，1例患者出现无症状支架闭塞，2例患者出现再狭窄，其中1例70%成功地接受了二次支架置入，另1例70%成功地接受了涤纶补片闭合支架置入。估计1年、3年和5年的再狭窄自由度分别为99.4%、97.5%和97.5%。估计1年时同侧卒中自由率为99.6%，3年时为98.7%，5年时为98.7%。精算生存率为1年97,4%，3年92,4%，5年77,7%。结论：初步数据表明，EPS CGuard支架是治疗颈动脉狭窄的有效和安全的装置，可接受的围手术期和中期神经事件低，持久的通畅率。我们提倡进行更大规模的多中心随机研究来证实这些发现。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Vascular Surgery 医学-外科

CiteScore

7.70

自引率

18.60%

发文量

1469

审稿时长

54 days

期刊介绍： Journal of Vascular Surgery ® aims to be the premier international journal of medical, endovascular and surgical care of vascular diseases. It is dedicated to the science and art of vascular surgery and aims to improve the management of patients with vascular diseases by publishing relevant papers that report important medical advances, test new hypotheses, and address current controversies. To acheive this goal, the Journal will publish original clinical and laboratory studies, and reports and papers that comment on the social, economic, ethical, legal, and political factors, which relate to these aims. As the official publication of The Society for Vascular Surgery, the Journal will publish, after peer review, selected papers presented at the annual meeting of this organization and affiliated vascular societies, as well as original articles from members and non-members.