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Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy — KAIZEN  

Peripheral Artery Disease Clinical Trial

Official title:
KAIZEN: Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05529472
Study type Interventional
Source Abbott Medical Devices
Contact Clinical Trial Lead
Phone +1 (651) 259-1600
Email KAIZEN@CSI360.com
Status Recruiting
Phase N/A
Start date January 10, 2023
Completion date November 2025
View Details
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