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Evaluation of a new dual-layer micromesh stent system for the carotid artery: 12-month results from the CLEAR-ROAD study

Bosiers et al.

Featured product: Roadsaver™ Carotid Artery Stent

11/9/2022 -  

Objective

To evaluate the clinical outcomes of carotid artery stenting (CAS) using 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 12-month 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 range: 48-89; 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 NIH Stroke Scale)
    • Physical examination and Concomitant medication registration


Methods

  • The CAS procedure was performed according to the physician’s standard of care. 
  • The recommended concomitant medication during the 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) 


Results

  • Successful stent implantation: 100/100
  • 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 fibrillation 
  • Between days 31-365 post-procedure:
    • 3 more patients experienced an ipsilateral stroke (all on DAPT for only a month and at the time of stroke on aspirin)
  • At 12 months  
    • 95.8 % of all patients were free of ipsilateral stroke
  • At 12 months as per the DUS examination and NASCET guidelines
    • 92.5% of patients were free from patency loss (>50% In-Stent Restenosis (ISR)) 
    • 97.9 of patients were free from target lesion revascularization (TLR)


Conclusion

The 12-month 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 a valid treatment alternative in both symptomatic and asymptomatic patients.


Link to the full publication: https://doi.org/10.4244/eij-d-18-00230