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

Physician: Bosiers M, Deloose K, Torsello G, Scheinert D, Lieven M, Peeters M, MD, Müller-Hülsbeck S, Sievert H, Langhoff R,  Bosiers M, Setacci C EuroIntervention. 2016;12(5):e671-6.

Location: Dept of Vascular Surgery, A.Z. Sint-Blasius, Belgium; Clinic for Vascular and Endovascular Surgery, University Hospital Munster, Germany; University of Leipzig, Germany;  Dept of Cardiovascular and Thoracic Surgery, OLV Hospital, Belgium;

Featured product: Roadsaver™ Carotid Artery Stent

​Aim

To evaluate the 30-day clinical outcome of Roadsaver carotid stent in non-consecutive subjects at high risk for carotid endarterectomy requiring revascularisation


Study group

  • CLEAR-ROAD is a prospective, multinational, single-arm, IIT
  • 100 non-consecutive patients in 9 centres  (BE, IT and GE) 
  • 31% symptomatic patients


Results

  • Technical success: 100%
  • The 30-day MAE: 2.1% (1 MI -> death / 1 minor stroke - AF)
  • Symptomatic vs Asymptomatic patients – no difference
  • EPD vs no-EPD use – no difference
  • No ISR (>50% DS)

​​Procedural characteristics
​Mean procedural time
​38.7±12.3 min (range 18-72)
​Mean fluoroscopy time
​​9.3±5.0  min (range 0.3-38)
​EPD
​58%
​​Pre-procedural DS
​​85.3±8.0 % (range 55-99)
​​Post-procedural residual stenosis 
​5.2±7.4 % (range 0-40)


​
Conclusions

The 30-day outcome shows that the Roadsaver stent is a safe and effective device for treatment of subjects at high risk for CEA and can be a valid alternative in both symptomatic and asymptomatic patients.


Abbreviations

  • CAS: Carotid Artery Stenting
  • CEA: Carotid Endarterectomy
  • Sx: Symptomatic
  • Ax: Asymptomatic
  • AF: Atrial Fibrillation
  • DS: Diameter Stenosis
  • IIT: Investigator-Initiated Trial
  • ISR: In-Stent Restenosis
  • EPD: Embolic Protection Device
  • MAE: Major Adverse Events (any death, stroke or MI)
  • MI: Myocardial Infarction  

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