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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

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