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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05873452




Registration number
NCT05873452
Ethics application status
Date submitted
20/03/2023
Date registered
24/05/2023

Titles & IDs
Public title
Kaitoh Atherectomy FIH
Scientific title
Kaitoh Atherectomy System: Peripheral Artery Revascularization of Stenotic/Restenotic Disease Using the Atherectomy System in the Peripheral Arteries
Secondary ID [1] 0 0
TIS2021-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Kaitoh Atherectomy System

Experimental: Kaitoh Atherectomy System - Eligible participants will undergo atherectomy using the Kaitoh Atherectomy System.


Treatment: Devices: Kaitoh Atherectomy System
The Kaitoh Atherectomy System is a handheld device which initiates mechanical rotation of the blade to debulk atherosclerotic lesions.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Freedom from major adverse events (MAEs)
Timepoint [1] 0 0
30 days post-procedure
Primary outcome [2] 0 0
Technical success as confirmed by angiography core lab
Timepoint [2] 0 0
through completion of interventional 1 day procedure

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Terumo Medical Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Holden
Address 0 0
Auckland City Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Samantha Sparks
Address 0 0
Country 0 0
Phone 0 0
609-613-6329
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05873452