Peripheral Arterial DiseaseNCT05873452
Kaitoh Atherectomy FIH
A study testing Kaitoh Atherectomy System in people with Peripheral Arterial Disease, run by Terumo Medical Corporation at 2 sites in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Kaitoh Atherectomy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 7 Aug 2023to 5 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
Auckland Hospital
Auckland, 1023
Waikato Hospital
Hamilton
About this study
Official title: 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Kaitoh Atherectomy System
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kaitoh Atherectomy SystemDevice
The Kaitoh Atherectomy System is a handheld device which initiates mechanical rotation of the blade to debulk atherosclerotic lesions.
| Study group | Role | What they receive |
|---|---|---|
| Kaitoh Atherectomy System | Experimental | Eligible participants will undergo atherectomy using the Kaitoh Atherectomy System. Receives: Device: Kaitoh Atherectomy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from major adverse events (MAEs)
Primary Safety
Measured: 30 days post-procedure
Technical success as confirmed by angiography core lab
Effectiveness
Measured: through completion of interventional 1 day procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start7 Aug 2023
- Primary completion20 Mar 2025
- Study completion5 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Holden, Principal investigator, Auckland City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873452
- Sponsor's protocol ID
- TIS2021-02
- Status last verified
- Sep 2025
- First submitted
- 20 Mar 2023
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not sharing IPD
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kaitoh Atherectomy System: Peripheral Artery Revascularization of Stenotic/Restenotic Disease Using the Atherectomy System in the Peripheral Arteries
- ClinicalTrials.gov ID
- NCT05873452
- Acronym / sponsor ID
- TIS2021-02
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Terumo Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 5 Aug 2025 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kaitoh Atherectomy System | Experimental | Device: Kaitoh Atherectomy SystemEligible participants will undergo atherectomy using the Kaitoh Atherectomy System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kaitoh Atherectomy SystemThe Kaitoh Atherectomy System is a handheld device which initiates mechanical rotation of the blade to debulk atherosclerotic lesions. | Device | Kaitoh Atherectomy System |
Primary outcome
Freedom from major adverse events (MAEs)
Time frame: 30 days post-procedure
Primary Safety
Technical success as confirmed by angiography core lab
Time frame: through completion of interventional 1 day procedure
Effectiveness
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No. Not sharing IPD
Related trials for Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 1
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
Familial Erythromelalgia
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 1
A Bioequivalence and Safety Study of AJU-B718 and B718R in Healthy Adult Volunteers Under Fasting Conditions
Peripheral Arterial Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Holden principal investigator
Auckland City Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kaitoh Atherectomy System in people with Peripheral Arterial Disease, run by Terumo Medical Corporation at 2 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from major adverse events (MAEs) (time frame: 30 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.