Post-Approval Study Of Transcarotid Artery Revascularization In Patients With Significant Carotid Artery Disease
- The ROADSTER 2 Study is an open label, single arm, multi-center post-approval Study for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and who are eligible for treatment with a combination of the ENROUTE Transcarotid Stent System and the ENROUTE Transcarotid NPS
- The study involves patients with atherosclerotic extracranial internal carotid stenosis (ICA) with or without involvement of the contiguous common artery (CCA) determined by duplex ultrasound, CT/CTA, MR/MRA or angiography to be: Symptomatic (≥ 50% stenosis) or Asymptomatic (≥ 80% stenosis)
Are you Eligible? (Inclusion Criteria)
- Patient is ≥18 years of age
- 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; NIHSS ≤4 or mRS ≤2), TIA and/or amaurosis fugax within 180 days of the procedure ipsilateral to the carotid artery to be stented
- Asymptomatic: Stenosis must be >80% as determined by angiogram without any neurological symptoms within the prior 180 days.