SKYWARD

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)

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Carotid artery disease
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All genders
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Overview
Principal Investigator: Shivani Kumar, MD

This is a prospective, multi-center, single-arm, investigational device exemption (IDE) study whose objective is to assess the safety and effectiveness of the Shockwave Medical SkyRunner Carotid IVL System for the treatment of calcified carotid arteries prior to stenting with commercially available trans-carotid stent systems in patients at high risk for complications from carotid endarterectomy (CEA).

Study details
Inclusion Criteria
  • Patient must have a life expectancy > 1 year at the time of the index procedure, in the opinion of the investigator at the time of enrollment, with no planned major cardiac intervention or surgery within 30 days following the index procedure.
  • Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the carotid bifurcation.
  • Patient has evidence of circumferential calcification of the stenotic lesion defined as ≥ 3 mm thickness of calcification as determined by Computed Tomography Angiography (CTA). MR angiography may be used in place of CTA for patients with a relative or absolute contraindication to CTA.
Exclusion Criteria
  • 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.

  • Patient with a history of major stroke with substantial neurological deficit (NIHSS ≥ 5 or mRS ≥ 3) within 1 month of index procedure.
  • 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.
Study Requirements

Approximately 16 months of study enrollment, and total study duration of 40 months. Study subjects will be followed through discharge, 30 days, 6, 12, and 24 months.