Trials / Completed
CompletedNCT05873452
Kaitoh Atherectomy FIH
Kaitoh Atherectomy System: Peripheral Artery Revascularization of Stenotic/Restenotic Disease Using the Atherectomy System in the Peripheral Arteries
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Terumo Medical Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Kaitoh Atherectomy System | The Kaitoh Atherectomy System is a handheld device which initiates mechanical rotation of the blade to debulk atherosclerotic lesions. |
Timeline
- Start date
- 2023-08-07
- Primary completion
- 2025-03-20
- Completion
- 2025-08-05
- First posted
- 2023-05-24
- Last updated
- 2025-09-10
Locations
2 sites across 1 country: New Zealand
Source: ClinicalTrials.gov record NCT05873452. Inclusion in this directory is not an endorsement.