Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07062471 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this 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)

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 4 of 12 entries
    • Site details revised at 7 of 25 sites
  2. Recruitment opened
    • Trial sites expanded: 0 → 25 locations
    • Start date changed from estimate of May 2026 to Jun 22, 2026
    v3
  3. Start date: Jan 2026 to May 2026v2 Show 7 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 160 to 185
    • Primary completion date: May 2027 to Oct 2027
    • Study completion date: Jun 2029 to Oct 2032
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints revised (12)
    • Study description expanded, about 42 words
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
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
(from sponsor)		 Carotid Artery Calcification, Carotid Artery Diseases
Related terms Calcinosis, Carotid Artery Diseases
Enrollment 185 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov