POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE. The ROADSTER 2 Study.

⁃ 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 \<30%.

‣ L. Patient has had a myocardial infarction \> 72 hours and \< 6 weeks prior to procedure.

‣ M. Patient has severe pulmonary disease (COPD) with either:

• FEV1 \<50% predicted or

• chronic oxygen therapy or

• resting PO2 of \<60 mmHg (room air)

‣ N. Patient has permanent contralateral cranial nerve injury O. Patient has chronic renal insufficiency (serum creatinine \> 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