Peripheral Arterial Disease
Conditions
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.
Interventions
DEVICEKaitoh Atherectomy System
The Kaitoh Atherectomy System is a handheld device which initiates mechanical rotation of the blade to debulk atherosclerotic lesions.
Sponsors
Terumo Medical Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
New Zealand
Outcome results
None listed