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Investigational Study of SWM-831 to Treat Moderate and Severely Calcified Femoropopliteal Arteries

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: estimated 60 to confirmed 81v5
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 10 of 10 sites
    v4
  3. Study sites: 9 to 10
    • Primary completion date: Mar 1, 2027 to Jan 31, 2027
    v3
  4. Site details revised at 1 of 9 sitesv2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Disrupt PAD Japan is a prospective, multi-center, single-arm study of SWM-831 to treat moderate and severely calcified femoropopliteal arteries, prior to DCB or stenting.
Trial Details
NCT Number NCT06938854
Lead Sponsor Shockwave Medical, Inc.
Collaborators: IQVIA Pty Ltd, Massachusetts General Hospital, Yale University
Conditions
(from sponsor)		 Peripheral Arterial Disease
Related terms Peripheral Arterial Disease
Enrollment 81 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov