Thirty-day results from prospective multi-specialty evaluation of carotid artery stenting using the CGuard MicroNet-covered embolic prevention system in real-world multicentre clinical practice: The IRON-Guard study

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.