POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE

INCLUSION CRITERIA

• 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 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.

• Target vessel must meet all requirements for ENROUTE Transcarotid Neuroprotection System and ENROUTE Stent System (refer to IFU for requirements).
• Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
• Patient is ≥18 years of age.
• Patient understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Institutional Review Board/Ethics Committee of the respective clinical site prior to the procedure. This will be obtained prior to participation in the study.
• Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
• 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.
• Patient meets at least one of the surgical high-risk criteria listed below.

Anatomic High Risk Inclusion Criteria:

A. Contralateral carotid artery occlusion B. Tandem stenoses >70% C. High cervical carotid artery stenosis D. Restenosis after carotid endarterectomy E. Bilateral carotid artery stenosis requiring treatment within 30 days after index treatment.

F. Hostile Necks which the Investigator deems safe for transcarotid access including but not limited to:

I. Prior neck irradiation II. Radical neck dissection III. Cervical spine immobility

Clinical High Risk Inclusion Criteria:

G. Patient is > 75 years of age H. Patient has > 2-vessel coronary artery disease and history of angina of any severity I. Patient has a history of angina

• Canadian Cardiovascular Society (CCS) angina class 3 or 4 or
• unstable angina

J. Patient has congestive heart failure (CHF) - New York Heart Association (NYHA)

• Functional Class III or IV

K. Patient has known severe left ventricular dysfunction

• LVEF 72 hours and 2.5 mg/dL).

REMINDER: The following is a list of anatomical considerations that are not suitable for transfemoral CAS with distal protection that are NOT contraindications for enrollment in the ROADSTER 2 Study including but not limited to:

I. TypeII, III, or Bovine arch II. Arch atheroma or calcification III. Atheroma of the great vessel origins IV. Tortuous distal ICA V. Tortuous or occluded iliofemoral segments VI. Occluded aortoiliac segments

EXCLUSION CRITERIA

Each potential patient must be screened to ensure that they do not meet any of the following exclusion criteria. This screening is to be based on known medical history and data available at the time of eligibility determination and enrollment.

• Patient has an alternative source of cerebral embolus, including but not limited to:
• Patient has chronic atrial fibrillation.
• Patient has had any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.
• Knowledge of cardiac sources of emboli. e.g. left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma).
• Recently ( 5 mm, AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal angiographic findings.
• Patient has a history of spontaneous intracranial