Kaitoh Atherectomy FIH

Kaitoh Atherectomy System: Peripheral Artery Revascularization of Stenotic/Restenotic Disease Using the Atherectomy System in the Peripheral Arteries

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Kaitoh Atherectomy System

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland Hospital
  • Hamilton, New Zealand
    • Waikato Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years old
• Rutherford Classification: 3-5 in target limb; Rutherford Classification 3 subjects may be enrolled but will be capped to a limit of 20% of the total enrollment (no more than two Rutherford Class 3 subjects may be enrolled into the study).
• Able and willing to provide informed consent, and comply with follow-up visits at both 30 days and 180 days (6 months)
• Able to comply with antiplatelet therapy as required
• Reference Vessel Diameter is ≥2.0 mm and ≤4.0 mm
• Target lesion length is ≤150 mm
• De novo or restenotic target lesion(s) (except for in-stent restenotic lesion) with stenosis ≥70%, by visual estimation, in a single limb in a single native vessel
• Inflow artery is patent, free from significant lesion stenosis (≥50% stenosis is considered significant) as visually confirmed by angiography. Note: Successful inflow artery treatment is allowed during the index procedure. Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤50% without major vascular complications (absence of flow limiting dissection, embolic event)
• Guidewire has successfully crossed the target lesion(s) within the true lumen

Exclusion Criteria:

• Females who are pregnant or lactating
• Pre-existing illness with life expectancy <1 year
• Known or suspected systemic infection
• Significant gastrointestinal bleeding or any coagulopathy that would preclude the use of anti-platelet therapy
• Subjects with a diagnosis of osteomyelitis and are currently on IV antibiotic therapy
• Endovascular or surgical procedure performed on the target lesion within 3 months of the index procedure
• Subjects who in the opinion of the Investigator have underlying kidney disease and may be at risk for contrast-induced acute kidney injury (AKI)
• Subjects who in the opinion of the Investigator have uncontrolled diabetes
• Allergic to iodine/radiopaque contrast that in the opinion of the Investigator cannot be adequately pre-treated
• History of Coronary Artery Bypass Graft (CABG), unstable angina pectoris, or myocardial infarction within 30 days and/or hemorrhagic stroke within 90 days
• Subjects scheduled to undergo a planned major amputation of the lower limb above the ankle on the target limb
• Allergic to any of the components of the atherectomy device system
• Intraprocedural complications prior to use of the investigational device
• Subjects with a positive COVID-19 test within the last 60 days and/or is symptomatic, at the Investigator's discretion
• Subject with other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre - and post-treatment
• Presence of flow-limiting stenosis (>50% diameter reduction) or occlusion of inflow vessels that was not successfully treated (<50% residual stenosis without flow limiting dissection) before the study intervention/prior to the point of enrollment
• No obvious angiographic evidence of flow to the foot following inflow treatment
• Co-existing aneurysmal disease requiring treatment
• Presence of vessel dissection at the target lesion requiring stent placement
• Clinical/angiographic evidence of distal embolization or acute thrombus
• Severe calcification that is measured >10mm in length and circumferential
• Prior stent placement in the target lesion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kaitoh Atherectomy System; Eligible participants will undergo atherectomy using the Kaitoh Atherectomy System.	Device: Kaitoh Atherectomy System; The Kaitoh Atherectomy System is a handheld device which initiates mechanical rotation of the blade to debulk atherosclerotic lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from major adverse events (MAEs)	Primary Safety	30 days post-procedure
Technical success as confirmed by angiography core lab	Effectiveness	through completion of interventional 1 day procedure

Collaborators and Investigators

• Sponsor: Terumo Medical Corporation
• Investigators: Principal Investigator: Andrew Holden, Auckland City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2023
• Primary Completion (Actual): March 20, 2025
• Study Completion (Actual): August 5, 2025

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: TIS2021-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not sharing IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No