Hopf-Jensen et al.​ Journal of Endovascular Therapy 2015

Featured product: Roadsaver™ Carotid Artery Stent

March 25, 2015

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

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• 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

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• 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

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• 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

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• The dual-layer micromesh Roadsaver^TM 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.

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