NCT06938854

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

Prospective, Multi-center, Single-arm Investigational Study of SWM-831 to Treat Moderate and Severely Calcified Femoropopliteal Arteries

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Shockwave Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Up to 60 subjects at up to 10 sites in Japan will be enrolled in the femoropopliteal clinical study with moderate and severely calcified femoropopliteal artery disease presenting with Rutherford Category 2 - 5 of the target limb. Two additional cohorts \[Iliac and BTK (Below-the-Knee)\] will enroll a minimum of 10 and a maximum of 15 subjects each with moderate and severely calcified iliac disease with a Rutherford Category (RC) 2 - 5 and a minimum of 10 and a maximum of 15 subjects with moderate and severely calcified BTK lesions with a Rutherford Category (RC) 2 - 5 will be enrolled and followed through 12 months. The estimated study duration for these cohorts is approximately 24 months. Study subjects will be followed through discharge, 30 days, 6, and 12 months.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-10
• Primary completion: 2027-01-31
• Completion: 2028-03-01
• First posted: 2025-04-22
• Last updated: 2025-12-11

Locations

10 sites across 1 country: Japan

Regulatory

• FDA-regulated device study