Clinical Trial

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)

Recruiting
View on ClinicalTrials.gov →
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-Carotid Stenting (SKYWARD Trans-Carotid IDE Study)
Protocol Amendment History 2 changes
critical Recruitment opened 2026-08-01
notable Trial sites expanded: 0 -> 25 locations 2026-08-01
Trial Details
NCT Number NCT07062471
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 2026-06-22
Primary Completion 2027-10 (estimated)
Study Completion 2032-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-31