- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05529472
Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy (KAIZEN)
July 17, 2023 updated by: Abbott Medical Devices
KAIZEN: Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy
This is a prospective, single-arm, multi-center study designed to evaluate the safety and efficacy of the Orbital Atherectomy System (OAS) for the treatment of adult Japanese subjects with a de novo symptomatic calcified occlusive atherosclerotic lesion in the superficial femoral artery (SFA) and/or popliteal (POP) artery, which would be otherwise ineligible for endovascular therapy due to risk of complication.
Study objective is to collect safety and effectiveness data to support potential commercialization of the peripheral OAS device in Japan.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clinical Trial Lead
- Phone Number: +1 (651) 259-1600
- Email: KAIZEN@CSI360.com
Study Locations
-
-
-
Osaka, Japan
- Recruiting
- Daini Osaka Police Hospital
-
-
Chiba
-
Urayasu, Chiba, Japan
- Recruiting
- Tokyo bay Ichikawa
-
-
Ehime
-
Matsuyama, Ehime, Japan
- Recruiting
- Matsuyama Red Cross
-
-
Fukuoka
-
Sawara, Fukuoka, Japan
- Recruiting
- Fukuoka Sannou
-
-
Fukushima
-
Iwaki, Fukushima, Japan
- Recruiting
- Iwaki-City Medical Center
-
-
Kanagawa
-
Kamakura-city, Kanagawa, Japan
- Recruiting
- Shonan Kamakura General Hospital
-
Contact:
- Phone Number: 0467-46-1717
-
-
Kyoto
-
Nishikyo-ku, Kyoto, Japan
- Recruiting
- Kyoto Katsura Hospital
-
-
Miyagi
-
Sendai, Miyagi, Japan
- Recruiting
- Sendai Kousei Hospital
-
-
Nara
-
Kashihara, Nara, Japan
- Recruiting
- Nara Medical University
-
-
Osaka
-
Joto, Osaka, Japan
- Recruiting
- Morinomiya
-
-
Saitama
-
Ageo, Saitama, Japan
- Recruiting
- Ageo Central Hospital
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Kasukabe, Saitama, Japan
- Recruiting
- Kasukabe Central (Chu-o-)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
General Inclusion Criteria (≤30 Days from Clinical Trial Treatment):
- 18 years of age or older
- Subject has signed the approved KAIZEN study Informed Consent Form prior to any study-related procedures
- Chronic, symptomatic lower limb ischemia
- Clinical indication for percutaneous transluminal angioplasty intervention in the native SFA and/or POP artery
General Exclusion Criteria (≤30 Days from Clinical Trial Treatment):
- Female who is pregnant and/or breastfeeding
- Currently participating in another investigational clinical study
- Unwilling to follow the Investigator's instructions or follow-up requirements
- Any non-diagnostic peripheral vascular intervention that was unsuccessful or had complications within 30 days before clinical trial treatment
- Any non-diagnostic coronary intervention within 30 days before clinical trial treatment
- Any planned non-diagnostic vascular intervention(s) within 30 days after clinical trial treatment
- Any planned procedures or other medical conditions which, in the Investigator's opinion, may interfere with the study result and/or subject's optimal participation in the study
- Prior major amputation within one year of the clinical trial treatment procedure
- Planned major amputation
- Life expectancy of ≤6 months
- History of coagulopathy or hypercoagulable bleeding disorder
- History of MI, or stroke/cerebrovascular accident within 6-months prior to the clinical trial treatment
- Unstable angina pectoris
- Untreatable hemorrhagic disease or platelet count <80,000mm3 or >600,000mm3
- Evidence of active infection
- Known hypersensitivity or contraindication to contrast dye
- Known hypersensitivity/allergy to the investigational atherectomy system or protocol-related therapies
- Known contraindication to antiplatelet therapy
- Creatinine > 2.5 mg/dL, unless on dialysis
Clinical Trial Treatment Inclusion:
- De novo target lesion
- All guidewires cross the Target Lesion within the true lumen
- Target lesion with ≥70% stenosis
- Target reference vessel diameter (RVD) ≥3.0 mm and ≤6.0 mm
- Target lesion length ≤150 mm
- Minimum one patent tibial vessel on the target leg
- Target lesion has visual evidence of calcification
Clinical Trial Treatment Exclusion:
- Any Inflow treatment that was unsuccessful or had complications during the clinical trial treatment, prior to subject enrollment
- Target lesion is a chronic total occlusion
- Presence of any other lesions in the target limb requiring a planned surgical intervention or endovascular procedure 30-days after clinical trial treatment
- Presence of aneurysm in the target vessel
- Acute ischemia and/or acute thrombosis of the SFA and/or POP artery
- Angiographic evidence of perforation
- Angiographic evidence of severe dissection
- Planned use of atherectomy other than CSI Peripheral OAS in the target limb
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CSI Peripheral Orbital Atherectomy System (OAS)
Treatment with OAS followed by POBA (pre-dilation) and DCB (Medtronic IN.PACT Admiral)
|
Treatment with OAS followed by POBA (pre-dilation) and DCB (Medtronic IN.PACT Admiral)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Subjects with Acute Device Success
Time Frame: Immediate post-procedure
|
Post-procedure acute device success
|
Immediate post-procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Target Vessel Patency
Time Frame: 6 months
|
Target Vessel Patency at 6 months post-procedure
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Hiroyoshi Yokoi, MD, International University of Health and Welfare, Japan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2023
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
November 1, 2025
Study Registration Dates
First Submitted
September 2, 2022
First Submitted That Met QC Criteria
September 2, 2022
First Posted (Actual)
September 7, 2022
Study Record Updates
Last Update Posted (Actual)
July 18, 2023
Last Update Submitted That Met QC Criteria
July 17, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLN-0013-P
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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