Post Approval

Post-Approval Study Of Transcarotid Artery Revascularization In Patients With Significant Carotid Artery Disease

Study Overview

  • 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.

Specialty Area(s)


Trial Location

Claudia Musat MD
Columbia University
161 Fort Washington Avenue
5th Floor
New York, NY 10032
United States