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

AIMS: The aim of the present study was to evaluate periprocedural and 30-day outcomes in a prospective series of patients treated with the CGuard Embolic Prevention System (EPS). METHODS AND RESULTS: From April 2015 to June 2016, a physician-initiated prospective multicentre study was performed in 200 consecutive patients admitted for protected carotid artery stenting (CAS) and treated using the CGuard EPS in twelve vascular centres. Outcome measures were: technical success, periprocedural (0-24 hours) and post-procedural (24 hours-30 days) major and minor strokes, death, acute myocardial infarction (AMI), transient ischaemic attack (TIA), and external carotid occlusion. In three centres, consecutive diffusion-weighted magnetic resonance cerebral imaging (DW-MRI) was performed ≤72 hours prior to and within 72 hours after the intervention. A distal embolic protection device was employed in 182 patients (91%). Technical success was 100%. No death, AMI or major stroke occurred periprocedurally. There were two TIAs and five periprocedural 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 post-procedural DW-MRI lesions were detected in 12 patients out of 61 (19.6%), including bilateral in five (8.2%) and isolated ipsilateral in six (9.8%), whereas one patient (1.6%) had contralateral only lesions. CONCLUSIONS: Multicentre multi-specialty use of the CGuard EPS in routine clinical practice was associated with no major periprocedural neurologic complications and a total elimination of post-procedural neurologic complications by 30 days.