Kaitoh Atherectomy FIH

Trial details

Who runs it

Terumo Medical Corporation

Trial code

NCT05873452

Record updated

10 September 2025

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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: 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; Allergic to iodine/radiopaque contrast that in the opinion of the Investigator cannot be adequately pre-treated; Intraprocedural complications prior to use of the investigational device; 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; Prior stent placement in the target lesion; Pre-existing illness with life expectancy <1 year; Known or suspected systemic infection; 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; History of Coronary Artery Bypass Graft (CABG), unstable angina pectoris, or myocardial infarction within 30 days and/or hemorrhagic stroke within 90 days; Allergic to any of the components of the atherectomy device system; Subjects with a positive COVID-19 test within the last 60 days and/or is symptomatic, at the Investigator's discretion; Co-existing aneurysmal disease requiring treatment; Significant gastrointestinal bleeding or any coagulopathy that would preclude the use of anti-platelet therapy; Females who are pregnant or lactating; Subjects scheduled to undergo a planned major amputation of the lower limb above the ankle on the target limb; No obvious angiographic evidence of flow to the foot following inflow 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.

ClinicalTrials.gov NCT05873452