Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure

Inclusion Criteria:

1. Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis:

   • Symptomatic: Stenosis must be greater than or equal to 50% as determined by angiogram and the patient has a history of stroke (minor or non-disabling), TIA and/or amaurosis fugax within 180 days of the procedure.
   • Asymptomatic: Stenosis must be greater than or equal to 70% as determined by angiogram without any neurological symptoms within the prior 180 days.
2. Target vessel must meet diameter requirements for stent (refer to selected stent IFU for diameter requirements).
3. Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
4. Patient is >18 years of age.
5. Patient has no childbearing potential or has a negative pregnancy test within one week prior to the study procedure.
6. Patient (or their legal guardian) understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Investigational Review Board/Ethics Committee of the respective clinical site prior to the procedure. This will be obtained prior to participation in the study.
7. Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
8. Patient meets at least one surgical high-risk criteria.

Exclusion Criteria:

1. Chronic atrial fibrillation, any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.
2. Evolving stroke, severe dementia, intracranial tumor, history of spontaneous intracranial hemorrhage within the past 12 months, recent stroke of sufficient size, hemorrhagic transformation of an ischemic stroke within the past 60 days, history of major ipsilateral stroke with major neurological deficit.
3. Active bleeding diathesis or coagulopathy or will refuse blood transfusion.
4. Had or will have CABG or vascular surgery within 30 days before or after the intervention.
5. Recent GI bleed that would interfere with antiplatelet therapy.
6. Life expectance of < 12 months post procedure.
7. History of intolerance or allergic reaction to any of the study medications or stent materials.
8. Myocardial Infarction within 72 hours prior to the intervention.
9. Has had neurologic illnesses within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke.
10. Has Hgb <10 g/dl, platelet count <125,000/μl, uncorrected INR >1.5, bleeding time >1 minute beyond upper limit normal, or heparin-associated thrombocytopenia.
11. Occlusion or (TIMI 0) "string sign" >1cm of the ipsilateral common or internal carotid artery.
12. Has vertebrobasilar insufficiency symptoms only, without clearly identifiable symptoms referable to the study carotid artery.
13. Knowledge of cardiac sources of emboli, Ostium of Common Carotid Artery (CCA) requires revascularization.
14. Presence of extensive or diffuse atherosclerotic disease involving the proximal common carotid artery that would preclude the safe introduction of the study device.
15. Has less than 5cm between the clavicle and bifurcation.
16. Bilateral carotid stenosis if intervention is planned within the 30-day of the index procedure.
17. An intraluminal filling defect that is not associated with an ulcerated target lesion.
18. Abnormal angiographic findings.
19. Previous intervention in the ipsilateral proximal CCA or previous placed intravascular stent in target vessel