Safety and Efficacy of the New Micromesh-Covered Stent CGuard in Patients Undergoing Carotid Artery Stenting

Early Experience From a Single Centre

Renato Casana, Valerio Tolva, Andrea Odero, Chiara Malloggi, Aldo Paolucci, Fabio Triulzi, Vincenzo Silani

Research output: Contribution to journalArticle

7 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)681-687
Number of pages7
JournalEuropean Journal of Vascular and Endovascular Surgery
Volume54
Issue number6
DOIs
Publication statusPublished - Dec 2017

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Carotid Arteries
Stents
Safety
Diffusion Magnetic Resonance Imaging
Stroke
Polyethylene Terephthalates
Brain
Thoracic Aorta
Anatomy
Pathologic Constriction
Thrombosis
Equipment and Supplies
Incidence

Keywords

  • Journal Article

Cite this

@article{c44c6adb06314acfbe4406d8b55d7769,
title = "Safety and Efficacy of the New Micromesh-Covered Stent CGuard in Patients Undergoing Carotid Artery Stenting: Early Experience From a Single Centre",
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 = "Journal Article",
author = "Renato Casana and Valerio Tolva and Andrea Odero and Chiara Malloggi and Aldo Paolucci and Fabio Triulzi and Vincenzo Silani",
note = "Copyright {\circledC} 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.",
year = "2017",
month = "12",
doi = "10.1016/j.ejvs.2017.09.015",
language = "English",
volume = "54",
pages = "681--687",
journal = "European Journal of Vascular and Endovascular Surgery",
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}

TY - JOUR

T1 - Safety and Efficacy of the New Micromesh-Covered Stent CGuard in Patients Undergoing Carotid Artery Stenting

T2 - Early Experience From a Single Centre

AU - Casana, Renato

AU - Tolva, Valerio

AU - Odero, Andrea

AU - Malloggi, Chiara

AU - Paolucci, Aldo

AU - Triulzi, Fabio

AU - Silani, Vincenzo

N1 - Copyright © 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

PY - 2017/12

Y1 - 2017/12

N2 - 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.

AB - 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.

KW - Journal Article

U2 - 10.1016/j.ejvs.2017.09.015

DO - 10.1016/j.ejvs.2017.09.015

M3 - Article

VL - 54

SP - 681

EP - 687

JO - European Journal of Vascular and Endovascular Surgery

JF - European Journal of Vascular and Endovascular Surgery

SN - 1078-5884

IS - 6

ER -