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

NCT06938854 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2025-12-11

No results posted yet for this study

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.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Peripheral Intravascular Lithotripsy (IVL)

For the Disrupt PAD Japan study, the Shockwave Medical Peripheral IVL System (SWM-831) is intended for lithotripsy enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the femoropopliteal arteries.

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • Massachusetts General Hospital

    collaborator OTHER

  • Yale University

    collaborator OTHER

  • Shockwave Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2027-01-31
Completion
2028-03-01
FDA Device
Yes

Countries

  • Japan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06938854 on ClinicalTrials.gov