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Initial clinical experience with micromesh RoadsaverTM carotid artery stent for the treatment of patients with symptomatic carotid artery disease

20/10/2022 -  

​Objective

This small, feasibility study was conducted to assess technical aspects, handling and performance of the dual layer micromesh RoadsaverTM carotid artery stent in the treatment of extracranial carotid artery disease and tandem lesions in ischemic stroke patients.


Study Group

  • Single-center, Single-arm, Case series
  • 7 patients (mean age: 75.0 ± 11.4 years, 5 males)
    • 5 symptomatic (elective) cases
    • 2 acute stroke (tandem lesions) cases


Methods

  • All patients:

    • 5000 IU Heparin: 7/7
    • Predilatation: 0/7
    • Embolic protection device (EPD) use: 0/7
    • Post-dilatation: 6/7
  • Elective patients:
    • DAPT for 3 days pre-procedure (aspirin & clopidogrel)
  • Acute patients:
    • CAS prior to Intracranial Thrombectomy
    • DAPT (intravenous aspirin (500 mg) & clopidogrel (300 mg) oral through the stomach tube)
    • No bridging therapy with recombinant tissue plasminogen activator 


Results

  • In all patients good navigability in
    • supra-aortic vessels
    • aortic arch types 1 - 3
    • in straight or elongated ICAs
  • Elective patients (N=5):
    • No peri-/post-procedural complications: 5/5
    • Clinical symptoms improvement: 5/5 (mRS)
    • ECA patent at 6 months: 5/5 (DUS)
  • Acute patients (N=2):
    • Time to recanalization pt1: 41 and pt2: 56 min
    • TICI 2b or greater flow in both patients.
    • No haemorrhagic transformation or parenchymal hematoma


Conclusion

  • The dual-layer micromesh RoadsaverTM carotid artery stent appears to be safe and effective. 

  • The stent displays sufficient radial force and vessel conformability in treatment of extracranial ICA stenoses and tandem lesions in the endovascular management of ischemic stroke.

Link to the full publication: https://doi.org/10.1177/1526602815576337