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Kaitoh Atherectomy FIH

NCT05873452 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-09-10

No results posted yet for this study

Summary

This is a prospective, multi-center and single-arm clinical study to assess the initial safety and effectiveness of the Kaitoh Atherectomy System for the treatment of de novo and/or restenotic lesion(s) in the peripheral arteries.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Kaitoh Atherectomy System

The Kaitoh Atherectomy System is a handheld device which initiates mechanical rotation of the blade to debulk atherosclerotic lesions.

Sponsors & Collaborators

  • Terumo Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Andrew Holden · Auckland City Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-07
Primary Completion
2025-03-20
Completion
2025-08-05

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05873452 on ClinicalTrials.gov