Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Carotid Stenting (SKYWARD Trans-Carotid IDE [Investigational Device Exemption] Study)

Exclusion Criteria

• •1. Patient has alternative source of cerebral embolus, including but not limited to:
• •1. a history of chronic atrial flutter or atrial fibrillation, or paroxysmal atrial flutter or atrial fibrillation requiring chronic anticoagulation
• •2. knowledge of cardiac sources of emboli (e.g., left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, hemodynamically significant aortic stenosis, endocarditis, mitral stenosis, or left atrial myxoma)
• •3. recently (\< 60 days) replaced/repaired heart valve (either surgically or percutaneously).
• •2. Patient has a history of spontaneous intracranial hemorrhage within the past 12 months, a hemorrhagic transformation of an ischemic stroke within the past 60 days or has had a recent stroke (\< 7 days) of sufficient size (on CT or MRI) to place the patient at risk of hemorrhagic conversion during the procedure.
• •3. Patient with a history of major stroke with substantial neurological deficit (NIHSS ≥ 5 or mRS ≥ 3) within 1 month of index procedure.
• •4. Patient has had a TIA, or amaurosis fugax within 48 hours prior to the procedure.
• •5. Patient has neurologic illnesses within the past 2 years characterized by fleeting or fixed neurologic or cognitive deficit which cannot be distinguished from TIA or stroke.
• •6. Patient has an intracranial tumor.
• •7. Patient has an isolated hemisphere.
• •8. Patient has an open stoma in the neck.
• •9. Patient has an unresolved/uncorrected bleeding disorder.
• •10. Patient had a myocardial infarction (MI) within last 72 hours prior to index procedure.
• •11. Patient has contralateral laryngeal, lateral recurrent, or vagus nerve injury.
• •12. Patient has history of intolerance or allergic reaction to contrast material that cannot be adequately premedicated or to any of the required study medications (i.e., antiplatelet agents, statins) or device materials (refer to IFUs).
• •13. Female patients who are pregnant, nursing, or may become pregnant.
• •14. Patient is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached its primary endpoint.
• •15. Patient has other medical, social, or psychological problems that, in the opinion of the investigator, would present difficulty in complying with protocol requirements.
• •16. Patient is on renal replacement therapy (i.e., dialysis).
• •17. Presence of a previously placed intravascular stent in the target vessel or ipsilateral CCA.
• •18. A significant CCA inflow or distal/intracranial lesion.
• •19. Occlusion (TICI 0) or "string sign" \> 1 cm of the ipsilateral common or internal carotid artery.
• •20. An intraluminal filling defect consistent with thrombus.
• •21. CCA disease that would preclude the use of TCAR per IFU.
• •22. Presence of extensive or diffuse atherosclerotic disease involving the aortic arch or proximal common carotid artery that would preclude the safe introduction of the study device.
• •23. Patient has \< 5 cm of distance between the clavicle and bifurcation, as assessed by duplex ultrasound.
• •24. Cerebral aneurysm, symptomatic or \> 5 mm or AVM (arteriovenous malformation) of the cerebral vasculature.
• •25. Massive exophytic (mushroom-like) or irregular endoluminal calcification seen on CTA or fluoroscopy.
• •26. Failure to successfully cross the guidewire across the target lesion; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow-limiting dissections or perforations.