The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Study
The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Study
The goal of this study is to evaluate the incidence of post procedure DW-MRI lesions
 (relative to baseline) and debris captured in the ENROUTE Transcarotid NPS inline filter
 during a transcarotid stenting procedure.
The ENROUTE Transcarotid NPS has received CE Mark and is commercially available in the
 European Union. The ENROUTE Transcarotid NPS may be used in conjunction with carotid artery
 stent approved for revascularization in patients with carotid disease in the context of this
 study.

 This is a prospective, single-arm, multi-center clinical trial of the ENROUTE Transcarotid
 NPS in conjunction with all commercially approved carotid artery stents used for
 revascularization in patients with carotid disease.

 The goal of this study is to evaluate the incidence of post procedure DW-MRI lesions
 (relative to baseline) and debris captured in the ENROUTE Transcarotid NPS inline filter
 during a transcarotid stenting procedure.

 A patient is considered enrolled after:

 1. meeting all inclusion and none of the exclusion criteria,

 2. the transcarotid arterial sheath has entered into the patient's vasculature. Insertion
 of the venous sheath does not qualify a patient as enrolled.

 Patients who are screened but do not meet all study criteria are considered screen failures
 and may not be enrolled. Patients in whom an arterial sheath is placed but who do not meet
 all study entry criteria are considered enrolled.

 The Investigator is responsible for maintaining any information pertaining to the Ethics
 Committee review and approval as required by local law.
Inclusion Criteria:

 -  Patient is symptomatic and has a history of stroke (minor or non-disabling), TIA
 and/or amaurosis fugax within 60 days of the procedure.

 -  Target vessel must meet diameter requirements for stent (refer to selected 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.

 Exclusion Criteria:

 -  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.

 -  Patient has an evolving stroke.

 -  Patient has a history of spontaneous intracranial hemorrhage within the past 12
 months.

 -  Patient 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.

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

 -  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.

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

 -  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 with a history of major stroke (CVA) with major neurological deficit likely to
 confound study endpoints within 1 month of index procedure.

 -  Patient has an intracranial tumor.

 -  Patient is actively participating in another 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.

 -  Occlusion or [Thrombolysis In Myocardial Infarction Trial (TIMI 0)] "string sign" >1cm
 of the ipsilateral common or internal carotid artery.

 -  Confirmed and uncorrected cardiac sources of emboli.

 -  Patient has a prosthetic heart valve

 -  Ostium of Common Carotid Artery (CCA) requires revascularization.

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

 -  The patient has less than 5cm between the clavicle and bifurcation, as assessed by
 duplex Doppler ultrasound.

 -  Bilateral carotid stenosis if intervention is planned within 37 days of the index
 procedure.

 -  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) that is not associated with an ulcerated target lesion.

 -  Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial
 stenosis 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 had a previous intervention in the ipsilateral proximal CCA.

 -  Patient is otherwise unsuitable for intervention in the opinion of the investigator