Kaitoh Atherectomy FIH

NCT05873452 | Completed

• 1 other identifier: TIS2021-02
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Kaitoh Atherectomy System

EXPERIMENTAL

Eligible participants will undergo atherectomy using the Kaitoh Atherectomy System.

Device: Kaitoh Atherectomy System

Interventions

Kaitoh Atherectomy System DEVICE

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

Kaitoh Atherectomy System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Terumo Medical Corporation: lead

Study Sites (2)

Auckland Hospital

Auckland, 1023, New Zealand

Location

Waikato Hospital

Hamilton, New Zealand

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Andrew Holden

  Auckland City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: May 24, 2023
• Study Start: August 7, 2023
• Primary Completion: March 20, 2025
• Study Completion: August 5, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2)