Kaitoh Atherectomy FIH

Terumo

Status

Active, not recruiting

Conditions

Peripheral Arterial Disease

Treatments

Device: Kaitoh Atherectomy System

Study type

Interventional

Funder types

Industry

Identifiers

NCT05873452

TIS2021-02

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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