Prospective, Multi-center, Single-arm 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 Study)
Age ≥ 18 years.
Patient is able and willing to comply with all assessments in the study.
Patient has been informed of the nature of the study, agrees to participate and has signed the approved informed consent form.
Patient approved for inclusion by a Patient Screening Committee.
a history of chronic atrial flutter or atrial fibrillation, or paroxysmal atrial flutter or 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, hemodynamically significant aortic stenosis, endocarditis, mitral stenosis, or left atrial myxoma)
recently (< 60 days) replaced/repaired heart valve (either surgically or percutaneously).
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.
Shockwave Medical, Inc.
Lead sponsor
Medpace, Inc.
Collaborator
Yale Cardiovascular Research Group
Collaborator
Cardiovascular Research Foundation, New York
Collaborator
Massachusetts General Hospital
Collaborator