Clinical trial NCT05873452: Kaitoh Atherectomy FIH
Official title: Kaitoh Atherectomy System: Peripheral Artery Revascularization of Stenotic/Restenotic Disease Using the Atherectomy System in the Peripheral Arteries
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Terumo Medical Corporation
Sponsor class: INDUSTRY
First posted: 2023-05-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Freedom from major adverse events (MAEs)
timeFrame: 30 days post-procedure
measure: Technical success as confirmed by angiography core lab
timeFrame: through completion of interventional 1 day procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Auckland Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
Study officials:
affiliation: Auckland City Hospital
name: Andrew Holden
role: PRINCIPAL_INVESTIGATOR
References: