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Eur J Vasc Endovasc Surg. 2017 Dec;54(6):681-687. doi: 10.1016/j.ejvs.2017.09.015. Epub 2017 Oct 28.

Safety and Efficacy of the New Micromesh-Covered Stent CGuard in Patients Undergoing Carotid Artery Stenting: Early Experience From a Single Centre.

Author information

1
Department of Surgery, IRCCS Istituto Auxologico Italiano, Milan, Italy. Electronic address: r.casana@auxologico.it.
2
Department of Vascular Surgery, Policlinico Di Monza Hospital, Monza, Italy.
3
Department of Surgery, IRCCS Istituto Auxologico Italiano, Milan, Italy.
4
Vascular Surgery Research Experimental Laboratory, IRCCS Istituto Auxologico Italiano, Milan, Italy.
5
Department of Neuroradiology (F.T.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.
6
Department of Neuroradiology (F.T.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.
7
Department of Neurology-Stroke Unit and Laboratory of Neuroscience, IRCCS Istituto Auxologico Italiano, Department of Pathophysiology and Transplantation, 'Dino Ferrari' Centre - University of Milan, Milan, Italy.

Abstract

OBJECTIVE/BACKGROUND:

Plaque protrusion through stent struts represents one of the principal causes of cerebral embolisation during carotid artery stenting (CAS) and the stent healing period. The aim of this study was to evaluate the safety (technical success) and efficacy (clinical success) of the CGuard stent system - a new nitinol stent covered by a closed-cell polyethylene terephthalate mesh designed to prevent embolic events.

METHODS:

Eighty-two consecutive patients who underwent CAS with CGuard from June 2015 were included in this study. The same surgeon performed all procedures. Primary endpoints included technical and clinical success. Clinical success was considered to be absence of death, major or minor stroke. The incidence of new ischaemic brain lesions was also evaluated by diffusion weighted magnetic resonance imaging (DW-MRI) in a subgroup of patients as a secondary endpoint.

RESULTS:

In this study, 82 patients (73.8 ± 8.5 years, 75% male, 19% symptomatic) underwent CAS procedures. Immediate technical success was 100%, with the stenosis diameter reduced from 81.4 ± 4.9% to 11.0 ± 3.5%. There was peri-operative technical and clinical success in 100% of symptomatic patients, and in 98.5% of asymptomatic patients, because of the occurrence of one acute stent thrombosis 4 hours post-CAS followed by a minor stroke. In the post-operative period (30 days), no new events were registered. The most recent 21 patients (24%) underwent DW-MRI in the peri-operative period: new ischaemic brain lesions were recorded in 23.8% of patients and the average lesion volume per patients was 0.039 ± 0.025 cm3.

CONCLUSIONS:

The technical and clinical outcomes of this single centre study suggest that the CGuard may be a safe and effective device for endovascular treatment of symptomatic and asymptomatic subjects, independent of aortic arch anatomy. Further larger comparative studies are needed to confirm these benefits.

KEYWORDS:

Carotid artery stenting; Carotid revascularisation; Mesh-covered stent

PMID:
29089282
DOI:
10.1016/j.ejvs.2017.09.015
[Indexed for MEDLINE]
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