No phaseRecruitingAge-related condition

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)

Sponsor
Shockwave Medical, Inc. (Industry)
Enrolment
185 planned
Conditions
Carotid Artery Calcification; Carotid Artery Diseases
Interventions
Carotid Intravascular Lithotripsy (IVL)
Ages
adults, older adults
Registry
NCT07062471

Full record on ClinicalTrials.gov

From the registry

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)

Primary outcomes

  • Composite endpoint with death, stroke, or myocardial infarction (MI) [Safety]

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered