Kaitoh Atherectomy FIH

Not Applicable

Active, not recruiting

• Conditions: Peripheral Arterial Disease
• Interventions: Device: Kaitoh Atherectomy System

• Registration Number: NCT05873452
• Lead Sponsor: Terumo Medical Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-05-23
• Study First Posted: 2023-05-24
• Study Start: 2023-08-07
• Primary Completion: 2025-03-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Presence of flow-limiting stenosis (>50% diameter reduction) or occlusion of inflow vessels that was not successfully treated (<50% residual stenosis without flow limiting dissection) before the study intervention/prior to the point of enrollment
• No obvious angiographic evidence of flow to the foot following inflow treatment
• Co-existing aneurysmal disease requiring treatment
• Presence of vessel dissection at the target lesion requiring stent placement
• Clinical/angiographic evidence of distal embolization or acute thrombus
• Severe calcification that is measured >10mm in length and circumferential
• Prior stent placement in the target lesion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Kaitoh Atherectomy System	Kaitoh Atherectomy System	Eligible participants will undergo atherectomy using the Kaitoh Atherectomy System.

Primary Outcome Measures

Name	Time	Method
Freedom from major adverse events (MAEs)	30 days post-procedure	Primary Safety
Technical success as confirmed by angiography core lab	through completion of interventional 1 day procedure	Effectiveness

Trial Locations

Locations (2)

Auckland Hospital; 🇳🇿 Auckland, New Zealand

Waikato Hospital; 🇳🇿 Hamilton, New Zealand