NCT05529472

Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy

KAIZEN: Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, multi-center study designed to evaluate the safety and efficacy of the Orbital Atherectomy System (OAS) for the treatment of adult Japanese subjects with a de novo symptomatic calcified occlusive atherosclerotic lesion in the superficial femoral artery (SFA) and/or popliteal (POP) artery, which would be otherwise ineligible for endovascular therapy due to risk of complication. Study objective is to collect safety and effectiveness data to support potential commercialization of the peripheral OAS device in Japan.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DEVICE	Peripheral Orbital Atherectomy System (OAS)	Treatment with Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA), pre-dilation and Drug Coated Balloon (DCB) - Medtronic IN.PACT™ Admiral™

Timeline

• Start date: 2023-01-10
• Primary completion: 2024-04-01
• Completion: 2024-10-10
• First posted: 2022-09-07
• Last updated: 2025-10-27
• Results posted: 2025-10-27

Locations

12 sites across 1 country: Japan

Regulatory

• FDA-regulated device study