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The CLEAR-ROAD study: evaluation of a new dual layer micromesh stent system for the carotid artery


7/11/2022 -  


To evaluate the clinical outcomes of carotid artery stenting (CAS) using the dual-layer micromesh RoadsaverTM stent in patients at high-risk for carotid endarterectomy (CEA), presenting lesions with significant stenosis with or without neurological symptoms. The present manuscript reports the 30-day results. 

Study Group

  • Prospective, Single-arm, Multi-centre, Multi-national, Investigator-initiated study
  • 9 centers  (Belgium (N=3), Italy (N=1) & Germany (N=5)) Enrolment between July 2015 and February 2016
  • 100 non-consecutive patients (Mean age: 73 ± 10, 70 males)
    • 31 symptomatic cases (≥50% stenosis via angiography with neurological symptoms (i.e. transient ischemic attack (TIA) and/or (minor) stroke within 30 days before enrolment)
    • 69 asymptomatic cases (≥80% stenosis via angiography without neurological symptoms)
  • 30-day, 6- and 12-month follow up visits were predefined for:
    • Adverse event recording 
    • Carotid duplex ultrasound (DUS) assessment 
    • Independent neurological assessment by a certified physician (as per National Institute of Stroke Scale (NIHSS))
    • Physical examination and Concomitant medication registration


  • The CAS procedure was performed according to the physician’s standard of care. 
  • The recommended concomitant medication during hospital stay and follow-up was as follows:
  • Aspirin 75-300 mg daily lifelong
  • Clopidogrel 75 mg daily for one month
  • The use of embolic protection devices (EPDs) was not mandatory 
  • EPD: 58/100
  • Predilatation: 21/100
  • Post-dilatation: 94/100
  • Mean procedural time was 39 ± 12 minutes (range 18-72)
  • Mean fluoroscopy time: 9 ± 5 minutes (range 0.3-38) 


  • Successful stent implantation: 100/100
    • Mean diameter stenosis (pre-procedure): 85 ± 8 % (range 55-99%)
    • Mean (residual) diameter stenosis (post-procedure): 5 ± 7 % (range 0-40%)
  • The 30-day Major Adverse Event (MAE) rate was 2.1% 
    • 1 patient experienced MI followed by death
    • 1 patient experienced a stroke within the first 14 days post-procedure due to inadequately medicated atrial fibrilation 
  • No notable differences in the 30-day MAE rate between symptomatic and asymptomatic patients, nor with or without EPD use.
  • At 30-day DUS no restenosis (>50%) within the implanted dual-layer micromesh RoadsaverTM carotid stent 
    • No primary patency loss 
    • No target lesion revascularization 


The 30-day outcomes show that the RoadsaverTM stent is a safe and effective device for endovascular treatment of subjects at high risk for CEA and may be considered as a valid treatm​ent alternative in both symptomatic and asymptomatic patients.

Link to the full publication: