Clinical Trial

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 [Investigational Device Exemption] Study)

Study acronym: SKYWARD TF
Not Yet Recruiting
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Summary
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)
Protocol Amendment History 1 change
notable Trial sites expanded: 0 -> 25 locations 2026-08-01
Trial Details
NCT Number NCT07512128
Lead Sponsor Shockwave Medical, Inc.
Collaborators: Medpace, Inc., Yale Cardiovascular Research Group, Cardiovascular Research Foundation, New York, Massachusetts General Hospital
Conditions Carotid Artery Calcification, Carotid Artery Diseases
Enrollment 185 participants
Start Date 2026-07
Primary Completion 2027-12 (estimated)
Study Completion 2032-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-31