Clinical Trial

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

Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-04-14; most recent amendment 2025-12-04.
Status change: Recruiting → Active, Not Recruiting 2025-10-30
Trial Details
NCT Number NCT06938854
Lead Sponsor Shockwave Medical, Inc.
Collaborators: IQVIA Pty Ltd, Massachusetts General Hospital, Yale University
Conditions Peripheral Arterial Disease
Enrollment 81 participants
Start Date 2025-03-10
Primary Completion 2027-01-31 (estimated)
Study Completion 2028-03-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-11