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In-Stent Restenosis associated with dual-layer Roadsaver carotid artery stent: a retrospective single-center study

10/11/2022 -  


To assess ISR rate in patients treated with the RoadsaverTM dual-layer micromesh stent.

Study Group

  • Retrospective, single arm, single center study 
    • CAS procedures performed between February 2017 and July 2018 
  • 13 patients (8 Men and 5 women (mean age: 75.8))
    • Symptomatic (≥50% by NASCET): 11 
      • 8 with Ipsilateral TIA or Amaurosis Fugax (within <6 months)  
      • 3 with ipsilateral strokes (within <6 months))
    • Asymptomatic (≥70% by NASCET & suitable for treatment): 2
  • 7 lipidic (echoluscent) / 5 heterogenous lesions
  • All patients presented at least 1 anatomic and comorbid clinical criteria that potentially increased risk posed by surgery (as per the SAPHIRE study)
  • Exclusion criteria 
    • Carotid obstruction, previous stenting at the same site, acute stroke within last 30 days, myocardial infarction within 72 hours and intracranial hemorrhage within last 12 months. 
  • Follow up at 12 months 
  • Neurological examinations of all  patients were performed before the intervention, by an independent neurologist using the National Institute of Health Stroke Scale (NIHSS)
  • Plaque morphology assessment by Doppler Ultrasound (DUS): categorizing all the plaques into lipidic (echoluscent), fibrotic (echogenic), and those with heterogenous texture (heterogenous plaque)     


  • Each patient was on Dual antiplatelet therapy (DAPT; aspirin 100 mg and clopidogrel 75mg daily for at least 3 days before the procedures on loading doses of 300 mg of aspirin and clopidogrel the day before the procedure.
  • All patients received 3000 – 5000 units of intravenous heparin after the establishment of endovascular access. 
  • Neurological examination was performed in all patients. 
  • Carotid stenosis was revealed by Doppler ultrasound (DUS) and multidetector CT (MDCT) scan. 
    • 4 patients had a peak systolic velocity (PSV) between 130 and 150 cm/s (50-69% stenosis), 
    • 6 a PSV between 150 and 180 cm/s (70-79%),
    • 3 a PSV > 180 cm/s (≥80% (severe) stenosis).  
  • EPD was used in 12/13 patients (11 Filter Wire EZ & 1 Spider FX)
  • Direct stenting: 11 (84.6%) cases, 
  • Predilatation: 2 (15.4%) cases 
  • In all cases postdilatation was performed. 
  • Stent patency was evaluated at 12-month follow-up. 
  • Patients were discharged 1-2 days after the procedure with the recommendation to take aspirin indefinitely and clopidogrel 75 mg for 3 months. 


  • Technical success (<30% residual stenosis): all (100%) cases. 
    • In 3 patients a nonsignificant residual stenosis <30% has been reported
  • No major complications during or after the procedure occurred
    • 1 patient (7.7%) showed a transitory bradycardia during angioplasty 
    • 1 patient (7.7%) showed local bleeding at the puncture site
  • All the neurological examinations performed 24 h and 30 days after the procedure were negative
  • No significant ISR was registered up to 12 months
    • In 2 patients, < 30% ISR was revealed at DUS performed after 6 months and confirmed at 12 months
      • In both patients contrast enhanced ultrasound (CEUS) and MDCT denied the presence of significant stenosis
      • One of the two patients already had insignificant (<30%) residua stenosis on the post-procedural angiogram


RoadsaverTM stent seems to be durable up to 12 months in terms of freedom from ISR. Further studies with larger populations and longer-term follow up are necessary to confirm these results.

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