The ROADSTER 2 Study is intended to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying experience with the transcarotid technique.
CRITERIA LIST/ QUALIFICATIONS:
Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis:
Symptomatic: Stenosis must be ≥ 50% as determined by an angiogram and the patient has a history of stroke (minor or non-disabling), TIA and/or amaurosis fugax within 180 days of the procedure ipsilateral to the carotid artery to be stented, OR
Asymptomatic: Stenosis must be ≥ 80% as determined by angiogram without any neurological symptoms within the prior 180 days.
Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
Patient must have a life expectancy ≥ 3 years at the time of the index procedure without contingencies related to other medical, surgical or endovascular intervention.