NCT07062471

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)

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)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 185 (estimated)
• Sponsor: Shockwave Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

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). Up to 160 subjects will be enrolled at up to 25 sites in the United States (US) in the primary analysis cohort. Additionally, one roll-in subject must be enrolled per site for up to 25 roll-in subjects. These roll-in subjects will not count toward the up to 160 subject target enrollment for the primary analysis cohort. The estimated study duration is approximately 76 months. Study subjects will be followed through discharge, 30 days, 6, 12, 24, 36, 48 and 60 months.

Conditions

• Carotid Artery Calcification
• Carotid Artery Diseases

Interventions

Type	Name	Description
DEVICE	Carotid Intravascular Lithotripsy (IVL)	The Shockwave Medical Intravascular Lithotripsy (IVL) System with the Shockwave SkyRunner Carotid IVL Catheter is intended for lithotripsy- enhanced balloon dilatation of ≥ 3 mm thick calcified lesions in the carotid arteries prior to stenting. Not for use for treating massive exophytic (mushroom-like) or irregular endoluminal carotid calcification, or in the coronary or cerebral arteries.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-10-01
• Completion: 2032-10-01
• First posted: 2025-07-14
• Last updated: 2026-04-03

Regulatory

• FDA-regulated device study