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

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

March 10, 2025

Primary Completion Date

January 31, 2027

Study Completion Date

March 1, 2028

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.

Trial Locations (10)

289-2511

NOT_YET_RECRUITING

Asahi General Hospital, Asahi

Unknown

RECRUITING

Tokyobay Urayasu Ichikawa, Chiba

NOT_YET_RECRUITING

Matsuyama Red Cross Hospital, Ehime

RECRUITING

Kokura Memorial Hospital, Fukuoka

RECRUITING

Caress Sapporo Tokeidai Memorial Hospital, Hokkaido

RECRUITING

Tokushukai Shonan Kamakura General Hospital, Kanagawa

RECRUITING

Sendai Kousei Hospital, Miyagi

RECRUITING

Nara Medical University Hospital, Nara

RECRUITING

Osaka International Medical & Science Center Daini Osaka Police Hospital, Osaka

RECRUITING

Toho University Ohashi Medical Center, Tokyo

All Listed Sponsors
collaborator

Iqvia Pty Ltd

INDUSTRY

collaborator

Massachusetts General Hospital

OTHER

collaborator

Yale University

OTHER

lead

Shockwave Medical, Inc.

INDUSTRY