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NCT05873452 Clinical Trial

Kaitoh Atherectomy FIH

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05873452
Other study ID # TIS2021-02
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 7, 2023
Est. completion date December 2024

Study information
Verified date April 2024
Source Terumo Medical Corporation
Contact Jennifer Stevens
Phone 908-208-4238
Email jennifer.stevens@terumomedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date December 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
New Zealand Auckland Hospital Auckland
New Zealand Waikato Hospital Hamilton

Sponsors (1)
Lead Sponsor Collaborator
Terumo Medical Corporation

Country where clinical trial is conducted

New Zealand, 

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