30-day results from prospective multi-specialty evaluation of carotid artery stenting using the CGuard micronet-covered embolic prevention stent system in real world multicenter clinical practice: the IRON-GUARD study

Francesco Speziale, Laura Capoccia, Pasqualino Sirignano, Wassim Mansour, Chiara Pranteda, Renato Casana, Carlo Setacci, Federico Accrocca, Domenico Alberti, Gianmarco de Donato, Michelangelo Ferri, Andrea Gaggiano, Giuseppe Galzerano, Arnaldo Ippoliti, Nicola Mangialardi, Giovanni Pratesi, Sonia Ronchey, Maria Antonella Ruffino, Andrea Siani, Angelo Spinazzola & 1 others Massimo Sponza

Research output: Contribution to journalArticle

Abstract

AIMS: The aim of the present study was to evaluate peri-procedural and 30-day outcomes in a prospective series of patients treated with the CGuard embolic prevention stent system (EPS).

METHODS AND RESULTS: From April 2015 to June 2016 a physician-initiated prospective multicenter study was performed in 200 consecutive patients admitted to protected carotid artery stenting (CAS) and treated using CGuard EPS in twelve Vascular Centers. Outcome measures were: technical success, periprocedural (0-24 hours) and post- procedural (24hours-30 days) major and minor strokes, death, acute myocardial infarction (AMI), transient ischemic attack (TIA), and external carotid occlusion. In 3 centres consecutive diffusion-weighted magnetic- resonance-cerebral imaging (DW-MRI) were performed ≤72 hours prior and within 72 hours after the intervention. Distal embolic protection device was employed in 182 patients (91%). Technical success was 100%. No death, AMI or major stroke occurred periprocedurally. There were 2 TIAs and 5 peri-procedural minor strokes (2.5%), including one thrombosis solved by surgery. In the remaining patients (199/200; 99.5%) one-month follow-up duplex ultrasound revealed optimal technical results. Post-procedural clinical follow- up was uneventful. No external carotid artery occlusion occurred. New postprocedural DW-MRI lesions were detected in 12 patients out of 61 (19.6%) including bilateral in 5 (8.2%) and isolated ipsilateral in 6 (9.8%) whereas 1 patient (1.6%) had contralateral-only lesions.

CONCLUSIONS: Multi-center multi-specialty use of the CGuard EPS in routine clinical practice was associated with no major peri-procedural neurologic complications and a total elimination of post-procedural neurologic complications by 30 days.

Original languageEnglish
JournalEuroIntervention
DOIs
Publication statusPublished - Feb 2018

Fingerprint

Carotid Arteries
Stents
Iron
Stroke
Nervous System
Embolic Protection Devices
Myocardial Infarction
Magnetic Resonance Imaging
External Carotid Artery
Transient Ischemic Attack
Multicenter Studies
Blood Vessels
Thrombosis
Outcome Assessment (Health Care)
Prospective Studies
Physicians

Keywords

  • Journal Article

Cite this

30-day results from prospective multi-specialty evaluation of carotid artery stenting using the CGuard micronet-covered embolic prevention stent system in real world multicenter clinical practice : the IRON-GUARD study. / Speziale, Francesco; Capoccia, Laura; Sirignano, Pasqualino; Mansour, Wassim; Pranteda, Chiara; Casana, Renato; Setacci, Carlo; Accrocca, Federico; Alberti, Domenico; de Donato, Gianmarco; Ferri, Michelangelo; Gaggiano, Andrea; Galzerano, Giuseppe; Ippoliti, Arnaldo; Mangialardi, Nicola; Pratesi, Giovanni; Ronchey, Sonia; Ruffino, Maria Antonella; Siani, Andrea; Spinazzola, Angelo; Sponza, Massimo.

In: EuroIntervention, 02.2018.

Research output: Contribution to journalArticle

Speziale, F, Capoccia, L, Sirignano, P, Mansour, W, Pranteda, C, Casana, R, Setacci, C, Accrocca, F, Alberti, D, de Donato, G, Ferri, M, Gaggiano, A, Galzerano, G, Ippoliti, A, Mangialardi, N, Pratesi, G, Ronchey, S, Ruffino, MA, Siani, A, Spinazzola, A & Sponza, M 2018, '30-day results from prospective multi-specialty evaluation of carotid artery stenting using the CGuard micronet-covered embolic prevention stent system in real world multicenter clinical practice: the IRON-GUARD study' EuroIntervention. https://doi.org/10.4244/EIJ-D-17-00008
Speziale, Francesco ; Capoccia, Laura ; Sirignano, Pasqualino ; Mansour, Wassim ; Pranteda, Chiara ; Casana, Renato ; Setacci, Carlo ; Accrocca, Federico ; Alberti, Domenico ; de Donato, Gianmarco ; Ferri, Michelangelo ; Gaggiano, Andrea ; Galzerano, Giuseppe ; Ippoliti, Arnaldo ; Mangialardi, Nicola ; Pratesi, Giovanni ; Ronchey, Sonia ; Ruffino, Maria Antonella ; Siani, Andrea ; Spinazzola, Angelo ; Sponza, Massimo. / 30-day results from prospective multi-specialty evaluation of carotid artery stenting using the CGuard micronet-covered embolic prevention stent system in real world multicenter clinical practice : the IRON-GUARD study. In: EuroIntervention. 2018.
@article{a50a09f2386b486eae5bab8674932b8f,
title = "30-day results from prospective multi-specialty evaluation of carotid artery stenting using the CGuard micronet-covered embolic prevention stent system in real world multicenter clinical practice: the IRON-GUARD study",
abstract = "AIMS: The aim of the present study was to evaluate peri-procedural and 30-day outcomes in a prospective series of patients treated with the CGuard embolic prevention stent system (EPS).METHODS AND RESULTS: From April 2015 to June 2016 a physician-initiated prospective multicenter study was performed in 200 consecutive patients admitted to protected carotid artery stenting (CAS) and treated using CGuard EPS in twelve Vascular Centers. Outcome measures were: technical success, periprocedural (0-24 hours) and post- procedural (24hours-30 days) major and minor strokes, death, acute myocardial infarction (AMI), transient ischemic attack (TIA), and external carotid occlusion. In 3 centres consecutive diffusion-weighted magnetic- resonance-cerebral imaging (DW-MRI) were performed ≤72 hours prior and within 72 hours after the intervention. Distal embolic protection device was employed in 182 patients (91{\%}). Technical success was 100{\%}. No death, AMI or major stroke occurred periprocedurally. There were 2 TIAs and 5 peri-procedural minor strokes (2.5{\%}), including one thrombosis solved by surgery. In the remaining patients (199/200; 99.5{\%}) one-month follow-up duplex ultrasound revealed optimal technical results. Post-procedural clinical follow- up was uneventful. No external carotid artery occlusion occurred. New postprocedural DW-MRI lesions were detected in 12 patients out of 61 (19.6{\%}) including bilateral in 5 (8.2{\%}) and isolated ipsilateral in 6 (9.8{\%}) whereas 1 patient (1.6{\%}) had contralateral-only lesions.CONCLUSIONS: Multi-center multi-specialty use of the CGuard EPS in routine clinical practice was associated with no major peri-procedural neurologic complications and a total elimination of post-procedural neurologic complications by 30 days.",
keywords = "Journal Article",
author = "Francesco Speziale and Laura Capoccia and Pasqualino Sirignano and Wassim Mansour and Chiara Pranteda and Renato Casana and Carlo Setacci and Federico Accrocca and Domenico Alberti and {de Donato}, Gianmarco and Michelangelo Ferri and Andrea Gaggiano and Giuseppe Galzerano and Arnaldo Ippoliti and Nicola Mangialardi and Giovanni Pratesi and Sonia Ronchey and Ruffino, {Maria Antonella} and Andrea Siani and Angelo Spinazzola and Massimo Sponza",
year = "2018",
month = "2",
doi = "10.4244/EIJ-D-17-00008",
language = "English",
journal = "EuroIntervention",
issn = "1774-024X",
publisher = "EuroPCR",

}

TY - JOUR

T1 - 30-day results from prospective multi-specialty evaluation of carotid artery stenting using the CGuard micronet-covered embolic prevention stent system in real world multicenter clinical practice

T2 - the IRON-GUARD study

AU - Speziale, Francesco

AU - Capoccia, Laura

AU - Sirignano, Pasqualino

AU - Mansour, Wassim

AU - Pranteda, Chiara

AU - Casana, Renato

AU - Setacci, Carlo

AU - Accrocca, Federico

AU - Alberti, Domenico

AU - de Donato, Gianmarco

AU - Ferri, Michelangelo

AU - Gaggiano, Andrea

AU - Galzerano, Giuseppe

AU - Ippoliti, Arnaldo

AU - Mangialardi, Nicola

AU - Pratesi, Giovanni

AU - Ronchey, Sonia

AU - Ruffino, Maria Antonella

AU - Siani, Andrea

AU - Spinazzola, Angelo

AU - Sponza, Massimo

PY - 2018/2

Y1 - 2018/2

N2 - AIMS: The aim of the present study was to evaluate peri-procedural and 30-day outcomes in a prospective series of patients treated with the CGuard embolic prevention stent system (EPS).METHODS AND RESULTS: From April 2015 to June 2016 a physician-initiated prospective multicenter study was performed in 200 consecutive patients admitted to protected carotid artery stenting (CAS) and treated using CGuard EPS in twelve Vascular Centers. Outcome measures were: technical success, periprocedural (0-24 hours) and post- procedural (24hours-30 days) major and minor strokes, death, acute myocardial infarction (AMI), transient ischemic attack (TIA), and external carotid occlusion. In 3 centres consecutive diffusion-weighted magnetic- resonance-cerebral imaging (DW-MRI) were performed ≤72 hours prior and within 72 hours after the intervention. Distal embolic protection device was employed in 182 patients (91%). Technical success was 100%. No death, AMI or major stroke occurred periprocedurally. There were 2 TIAs and 5 peri-procedural minor strokes (2.5%), including one thrombosis solved by surgery. In the remaining patients (199/200; 99.5%) one-month follow-up duplex ultrasound revealed optimal technical results. Post-procedural clinical follow- up was uneventful. No external carotid artery occlusion occurred. New postprocedural DW-MRI lesions were detected in 12 patients out of 61 (19.6%) including bilateral in 5 (8.2%) and isolated ipsilateral in 6 (9.8%) whereas 1 patient (1.6%) had contralateral-only lesions.CONCLUSIONS: Multi-center multi-specialty use of the CGuard EPS in routine clinical practice was associated with no major peri-procedural neurologic complications and a total elimination of post-procedural neurologic complications by 30 days.

AB - AIMS: The aim of the present study was to evaluate peri-procedural and 30-day outcomes in a prospective series of patients treated with the CGuard embolic prevention stent system (EPS).METHODS AND RESULTS: From April 2015 to June 2016 a physician-initiated prospective multicenter study was performed in 200 consecutive patients admitted to protected carotid artery stenting (CAS) and treated using CGuard EPS in twelve Vascular Centers. Outcome measures were: technical success, periprocedural (0-24 hours) and post- procedural (24hours-30 days) major and minor strokes, death, acute myocardial infarction (AMI), transient ischemic attack (TIA), and external carotid occlusion. In 3 centres consecutive diffusion-weighted magnetic- resonance-cerebral imaging (DW-MRI) were performed ≤72 hours prior and within 72 hours after the intervention. Distal embolic protection device was employed in 182 patients (91%). Technical success was 100%. No death, AMI or major stroke occurred periprocedurally. There were 2 TIAs and 5 peri-procedural minor strokes (2.5%), including one thrombosis solved by surgery. In the remaining patients (199/200; 99.5%) one-month follow-up duplex ultrasound revealed optimal technical results. Post-procedural clinical follow- up was uneventful. No external carotid artery occlusion occurred. New postprocedural DW-MRI lesions were detected in 12 patients out of 61 (19.6%) including bilateral in 5 (8.2%) and isolated ipsilateral in 6 (9.8%) whereas 1 patient (1.6%) had contralateral-only lesions.CONCLUSIONS: Multi-center multi-specialty use of the CGuard EPS in routine clinical practice was associated with no major peri-procedural neurologic complications and a total elimination of post-procedural neurologic complications by 30 days.

KW - Journal Article

U2 - 10.4244/EIJ-D-17-00008

DO - 10.4244/EIJ-D-17-00008

M3 - Article

JO - EuroIntervention

JF - EuroIntervention

SN - 1774-024X

ER -