The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Evaluation
The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Evaluation
The goal of this evaluation is to document the incidence of post procedure DW-MRI lesions
 (relative to baseline) in patients treated with the transcarotid artery revascularization
 (TCAR) procedure.
This is a prospective, single-arm, multi-center evaluation of patients requiring carotid
 revascularization who are treated with the FDA-cleared ENROUTE Transcarotid NPS in
 conjunction with the FDA-approved ENROUTE Transcarotid Stent System. Both the ENROUTE
 Transcarotid NPS and ENROUTE Transcarotid Stent System have received CE mark and are
 commercially available in the European Union.

 Patients enrolled in this study will have been offered the TCAR intervention as part of
 standard of care for the treatment of carotid artery stenosis, regardless of whether or not
 they agree to be in the study. Therefore, the act of participation in this procedure will not
 be the determining factor in whether or not the patient receives the TCAR treatment. Subject
 participation means they agree to undergo two additional DW-MRI imaging procedures
 immediately after the procedure and at 30 days to determine whether there is an increase in
 new white lesions. Any other procedure other than the active collection of consent and data
 by the sponsor is standard of care for the treatment of carotid artery stenosis.

 These patients will be monitored to document the incidence of post procedure DW-MRI lesions
 (relative to baseline).
Inclusion Criteria:

 -  Stenosis must be >50% as determined by ultrasound or angiogram1 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.

 -  Stenosis must be >80% as determined by ultrasound or angiogram without any
 neurological symptoms within the prior 180 days.

 -  Target vessel must meet diameter requirements for stent (refer to stent IFU for
 diameter 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 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 in CMS National
 Coverage Determination (NCD) for Percutaneous Transluminal Angioplasty (20.7)

 Exclusion Criteria

 -  Alternative source of cerebral embolus

 -  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 (<60 days) implanted heart valve (either surgically or endovascularly), which
 is a known source of emboli as confirmed on echocardiogram.

 -  Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial
 stenosis (as determined by angiography or CTA/MRA ≤ 6 months prior to index procedure)
 greater in severity than the lesion to be treated, cerebral aneurysm > 5 mm, AVM
 (arteriovenous malformation) of the cerebral vasculature, or other abnormal
 angiographic findings.

 -  Patient has a history of spontaneous intracranial hemorrhage within the past 12
 months, or has had a recent (<7 days) stroke of sufficient size (on CT or MRI) to
 place him or her at risk of hemorrhagic conversion during the procedure (less than
 one-third middle cerebral artery volume).

 -  Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.

 -  Patient with a history of major stroke attributable to either carotid artery (CVA or
 retinal embolus) with major neurological deficit (NIHSS ≥ 5 OR mRS ≥ 3) likely to
 confound study endpoints within 1 month of index procedure.

 -  Patient has an evolving stroke.

 -  Patient has an intracranial tumor.

 -  Patient has neurologic illnesses within the past two years characterized by fleeting
 or fixed neurologic deficit which cannot be distinguished from TIA or stroke,
 including but not limited to: moderate to severe dementia, partial or secondarily
 generalized seizures, complicated or classic migraine, tumor or other space-occupying
 brain lesions, subdural hematoma, cerebral contusion or other post-traumatic lesions,
 intracranial infection, demyelinating disease, or intracranial hemorrhage).

 -  Patient has had a TIA or amaurosis fugax within 48 hrs prior to the procedure.

 -  Patient has an isolated hemisphere defined as the ipsilateral middle cerebral artery
 being supplied only by the ipsilateral internal carotid artery.

 -  Patient has active bleeding diathesis or coagulopathy or will refuse blood
 transfusion.

 -  Patient had or will have CABG, endovascular stent procedure, valve intervention or
 vascular surgery within 30 days before or after the intervention.

 -  Myocardial Infarction within 72 hours prior to the intervention.

 -  Occlusion of the ipsilateral common or internal carotid artery.

 -  An intraluminal filling defect (defined as an endoluminal lucency surrounded by
 contrast, seen in multiple angiographic projections, in the absence of angiographic
 evidence of calcification) whether or not it is associated with an ulcerated target
 lesion.

 -  Patients with carotid string sign (a very high-grade carotid stenosis to the skull
 base with a long, thin, barely visible string of contrast within the true lumen of the
 artery.).

 -  Ostium of Common Carotid Artery (CCA) requires revascularization (>50% stenosis).

 -  Patient has an open stoma in the neck.

 -  Patients with hostile necks due to prior neck irradiation

 -  Female patients who are pregnant

 -  Patient has history of intolerance or allergic reaction to any of the study
 medications or stent materials (refer to stent IFU), including aspirin (ASA),
 ticlopidine, clopidogrel, prasugrel, statin or contrast media (that can't be pre
 medicated). Patients must be able to tolerate statins and a combination of ASA and
 ticlopidine, ASA and clopidogrel or ASA and prasugrel.

 -  Patient has a life expectancy <3 years with contingencies related to other medical,
 surgical, or interventional procedures as per the Wallaert Score and patients with
 primary, recurrent or metastatic malignancy who do not have independent assessment of
 life expectancy performed by the treating oncologist or an appropriate specialist
 other than the physician performing TCAR.

 -  Patient has had a recent GI bleed that would interfere with antiplatelet therapy.

 -  Patient is actively participating in an investigational drug or device trial (IND or
 IDE) that has not completed the required protocol follow-up period.

 -  Patient has inability to understand and cooperate with study procedures.

 -  Presence of extensive or diffuse atherosclerotic disease involving the proximal common
 carotid artery that would preclude the safe introduction of the study device.

 -  Patient is otherwise unsuitable for intervention in the opinion of the physician.

 -  Patients who cannot have MRI due to metallic implants (e.g. orthopedic implants,
 pacemakers, etc.)