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 SpinazzolaMassimo Sponza

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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

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  • Journal Article

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    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, M. A., Siani, 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