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-Femoral stenting (SKYWARD Trans-Femoral 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.
Single group
Carotid Intravascular Lithotripsy
DeviceThe Shockwave Medical Intravascular Lithotripsy (IVL) System with the Shockwave SkyRunner Carotid IVL Catheter is intended for lithotripsy- enhanced balloon dilatation of calcified lesions in the carotid arteries prior to stenting. Not for use treating massive exophytic (mushroom-like) or irregular endoluminal carotid calcification, or in the coronary or cerebral arteries.
Primary Endpoint: Composite endpoint with death, stroke, or myocardial infarction (MI) [Safety]
A composite endpoint with death, stroke (disabling or non-disabling based on NeuroARC definitions) or myocardial infarction (MI) (using the SCAI definition for peri-procedural MI and the 4th Universal Definition for spontaneous MI beyond 48 hours) at 30 days post procedure.
Incidence of any stroke
Incidence of any stroke through 30 days, 6, 12, 24, 36, 48 and 60 months of follow-up, categorized as: * Disabling or Non-disabling * Ipsilateral or Contralateral * Hemorrhagic, Ischemic, or Unknown
Proportion of subjects with Device Success without serious angiographic complications
Proportion of subjects with Device Success, defined as the ability of the IVL catheter to fully cross the target lesion and delivery of lithotripsy without core lab adjudicated serious angiographic complications, defined as severe dissection (Grade D to F), perforation, abrupt closure, or distal embolization on final angiography, as assessed by the core lab.
Proportion of subjects with residual diameter stenosis ≤ 50%
Proportion of subjects with stent delivery with a residual diameter stenosis ≤ 50% (core lab assessed) on final angiography.
Proportion of subjects with a residual stenosis of ≤ 30%
Proportion of subjects with stent delivery with a residual stenosis of ≤ 30% (core lab assessed) on final angiography.
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Shockwave Medical, Inc.
Lead sponsor
Medpace, Inc.
Collaborator
Yale Cardiovascular Research Group
Collaborator
Cardiovascular Research Foundation, New York
Collaborator
Massachusetts General Hospital
Collaborator
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