CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 81 enrolled
Drug / intervention
Peripheral Orbital Atherectomy System (OAS)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05529472
NCT05529472N/ACompleted
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KAIZEN: Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy

Abbott Medical Devices·interventional·Posted Sep 7, 2022·Updated Oct 27, 2025

In Brief

A clinical study evaluating Peripheral Orbital Atherectomy System (OAS) for Peripheral Artery Disease. Completed, enrolled 81 participants across 12 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Artery Disease
CountriesJapan
CollaboratorsICON plc

Timeline

N/ACompletedFinished
2023202420252026
First PostedSep 7, 2022
Enrollment StartJan 10, 2023
Primary CompletionApr 1, 2024
Study CompletionOct 10, 2024
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 3.8 years ago

Interventions

Peripheral Orbital Atherectomy System (OAS)device

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