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Incidence of New Ischaemic Brain Lesions After Carotid Artery Stenting with the Micromesh Roadsaver Carotid Artery Stent: A Prospective Single-Centre Study

9/11/2022 -  


This study examines the incidence of new ischemic brain lesions after carotid artery stenting (CAS) with the dual-layer micromesh RoadsaverTM carotid artery stent, measured by the Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI).

Study Group 

  • Prospective, Single-arm, Single-center
    • Enrolment between September 2015 - January 2016 at a high-volume Italian center
  • 23 consecutive patients (Mean age: 74 ± 7, 19 (82.6%) males) 
  • Principal inclusion criteria were 18 or more years of age and carotid artery stenosis 
    • 60.9 % (14) Symptomatic patients, with ≥50% evaluated by duplex ultrasound (DUS) according to the NASCET criteria 
    • 39.1 % (9)   Asymptomatic patients, with ≥80% and suitable for treatment according to the vascular and neurological specialist
  • Patients were scheduled for DW-MRI evaluations at baseline, 24 h and 30 days post-stenting, and clinical evaluation and DUS at baseline, 24 h, 30 days, and 6 months post-stenting
  • The clinical evaluation included a neurological examination performed by an independent neurologist using the National Institute of Health Stroke Scale (NIHSS) and cognitive tests as the Mini-Mental State Examination and the Frontal Assessment Battery
  • Procedural success was defined as stenting achieving <30 % residual stenosis with no complications 


  • The intracranial circulation was visualized before and after the procedurę. 
  • Co-medication:
    • Before the procedure, all patients received dual antiplatelet therapy (DAPT; i.e. 100 mg acetyl-salicylic acid (ASA) and a loading dose of 375 mg clopidogrel (unless already on DAPT)). 
    • During the procedure, ACT-based heparinization was administered using weight adjusted initial dosing. 1 mg of atropine was administered after stent dilatation.
    • After the procedure, patients received a daily dose of DAPT (100 mg ASA and 75 mg clopidogrel) for one month, and only ASA thereafter.
  • Embolic protection device (EPD) use: 100% 
    • Emboshield, Abbott Vascular in all patients
  • The same 2 operators with extensive experience (50 CAS/year as first operators in last 10 years) performed all procedures.
  • All MRI studies were performed with a 1.5 T scanner (Achieva, Philips, Best, The Netherlands).
    • For a detailed summary of different imaging parameters and related analyses, see the original manuscript.


  • The pre-procedural DW-MRI did not detect any acute ischemic lesions in any patient.
  • In 7/23 (30.4 %) patients the 24-h post-procedure imaging showed new asymptomatic (silent) ischemic cerebral lesions (4/7 stand-alone ipsilateral & 3/7 with additional contralateral lesions).
    • 15 new ipsilateral (median volume 0.076 cm3) ischemic lesions 
    • 6 contralateral (median volume 0.044 cm3) ischemic lesions 
  • The number of ipsilateral lesions in a single patient ranged from 1 to 4 (median 3 lesions/patient).
  • No statistically significant differences in the baseline (presence of risk factors) nor in the procedure management was detected among patients with and w/o the post-CAS cerebral embolization.
  • Most lesions were found in symptomatic patients (73 %) and in patients presenting with unstable plaques.
  • The 30-day imaging showed complete resolution of all lesions and no new ischemic lesions.
  • Follow-up clinical and ultrasound examinations at 30 days and 6 months recorded no adverse cardiac or cerebrovascular events, while the ECA was patent in all cases.


  • Protected stenting with a dual-layer micromesh RoadsaverTM stent shows good safety and efficacy in the treatment of carotid stenosis.
  • The incidence of new ischemic brain lesions after CAS with the Roadsaver stent indicates that this stent may exert intrinsic embolic protection and positively impact outcomes.

Link to the full publication: