Kaitoh Atherectomy FIH

• Sponsor: Terumo Medical Corporation (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05873452
• Collaborator: (none)
• Enrollment: 10
• Arm: 1
• Anticipated Duration (Months): 15

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease	Device: Kaitoh Atherectomy System	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Kaitoh Atherectomy System: Peripheral Artery Revascularization of Stenotic/Restenotic Disease Using the Atherectomy System in the Peripheral Arteries
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Freedom from major adverse events (MAEs) [30 days post-procedure]

   Primary Safety

2. Technical success as confirmed by angiography core lab [through completion of interventional 1 day procedure]

   Effectiveness

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age ≥18 years old

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

1. 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).

1. Able and willing to provide informed consent, and comply with follow-up visits at both 30 days and 180 days (6 months)

2. 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Terumo Medical Corporation

Investigators

• Principal Investigator: Andrew Holden, Auckland City Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Terumo Medical Corporation
• ClinicalTrials.gov Identifier: NCT05873452
• Other Study ID Numbers: TIS2021-02
• First Posted: May 24, 2023
• Last Update Posted: May 24, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases

Study Results

No Results Posted as of May 24, 2023