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, single-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: Recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Kaitoh Atherectomy System

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Stevens; Phone Number: 908-208-4238; Email: jennifer.stevens@terumomedical.com
• Study Contact Backup: Name: Samantha Sparks; Phone Number: 609-613-6329; Email: samantha.sparks@terumomedical.com

Study Locations

• New Zealand
  • Auckland, New Zealand, 1023
    • Recruiting
    • Auckland Hospital
    • Contact: Cynthia Corne
  • Hamilton, New Zealand
    • Not yet recruiting
    • Waikato Hospital
    • Contact: Mary La Pine

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age ≥18 years old

2. Rutherford Classification: 3-5 in target limb;

   a. 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).

3. Able and willing to provide informed consent, and comply with follow-up visits at both 30 days and 180 days (6 months)
4. Able to comply with antiplatelet therapy as required

Exclusion Criteria:

1. Females who are pregnant or lactating
2. Pre-existing illness with life expectancy <1 year
3. Known or suspected systemic infection
4. Endovascular or surgical procedure performed on the target lesion within 3 months of the index procedure
5. Subjects scheduled to undergo a planned major amputation of the lower limb above the ankle on the target limb
6. Allergic to any of the components of the atherectomy device system
7. Intraprocedural complications prior to use of the investigational device

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 (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

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 (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• 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