Kaitoh Atherectomy FIH

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 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