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Protection against Emboli during caRotid artery stenting using a 3-in-1 delivery system comprised oF a pOst-dilation balloon, integrated eMbolic filter, and A Novel Carotid stEnt II (Performance II)

  • Study HIC#:2000028243
  • Last Updated:07/15/2021

A study to understand the safety and efficacy of the Neuroguard IEP System for the treatment of carotid artery stenosis in subjects at elevated risk. The Neuroguard IEP System is a 3-in 1 carotid stent delivery system consisting of an angioplasty balloon, an integrated embolic protection device and a nitinol self-expanding stent loaded over the balloon and constrained by an outer sheath.

  • Age20 years - 80 years
  • GenderBoth
  • Start Date01/19/2021
  • End Date09/30/2022

Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Subjects between 20 and 80 years of age with either de novo atherosclerotic or post carotid endarterectomy (CEA) restenotic lesion(s) in the internal carotid artery (ICA) or at the carotid bifurcation with ≥ 50% stenosis if symptomatic of ≥ 80% stenosis if asymptomatic (both defined by angiography using NASCET methodology) at elevated risk for adverse events following CEA.

 Exclusion Criteria: 

Symptomatic subjects are defined as having ipsilateral transient monocular blindness: amaurosis fugax; ipsilateral carotid transient ischemic attack (TIA), with neurologic symptoms persisting less than 24 hours; or ipsilateral non-disabling stroke within 180 days of the procedure.

Sub-Investigator

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