Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy (KAIZEN)

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: Completed
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: Peripheral Orbital Atherectomy System (OAS)

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan
    • Daini Osaka Police Hospital
  • Chiba
    • Urayasu, Chiba, Japan
      • Tokyo bay Ichikawa
  • Ehime
    • Matsuyama, Ehime, Japan
      • Matsuyama Red Cross
  • Fukuoka
    • Sawara, Fukuoka, Japan
      • Fukuoka Sannou
  • Fukushima
    • Iwaki, Fukushima, Japan
      • Iwaki-City Medical Center
  • Kanagawa
    • Kamakura, Kanagawa, Japan
      • Shonan Kamakura General Hospital
  • Kyoto
    • Nishikyo-ku, Kyoto, Japan
      • Kyoto Katsura Hospital
  • Miyagi
    • Sendai, Miyagi, Japan
      • Sendai Kousei Hospital
  • Nara
    • Kashihara, Nara, Japan
      • Nara Medical University
  • Osaka
    • Joto, Osaka, Japan
      • Morinomiya
  • Saitama
    • Ageo, Saitama, Japan
      • Ageo Central Hospital
    • Kasukabe, Saitama, Japan
      • Kasukabe Central (Chu-o-)

Participation Criteria

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 Myocardial Infarction (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 Cardiovascular Systems, Inc. (CSI) Peripheral OAS in the target limb

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peripheral Orbital Atherectomy System (OAS); Treatment with Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA) pre-dilation and Medtronic IN.PACT™ Admiral™ Drug Coated Balloon (DCB)	Device: Peripheral Orbital Atherectomy System (OAS); Treatment with Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA), pre-dilation and Drug Coated Balloon (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	The percentage of subjects with the following, post-procedure: ≤50% residual stenosis post OAD + POBA [Angiographic Core Lab assessed] and,; No OAS-related severe angiographic complications defined as severe dissections (D-F), perforation, or distal emboli requiring additional treatment during the procedure [CEC adjudicated].	At the end of the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Lesion Stenosis	The percentage changes in diameter stenosis of the target lesion at each stage of the procedure: Baseline, Post OAD, Post POBA and Post DCB [Angiographic Core Lab assessed].	Baseline, Post OAD, Post POBA
Acute Technical Success	Acute technical success defined per the Peripheral Academic Research Consortium (PARC) definition of achievement of a final residual stenosis <30% for stented and <50% for non-stented subjects by angiography at the end of the procedure [Angiographic Core Lab assessed] without severe angiographic complications defined as severe dissections (D-F), perforation, or distal emboli requiring additional treatment during the procedure [CEC adjudicated].	At the end of the procedure
Drug Coated Balloon (DCB) Device Success	DCB Device Success defined as the ability to achieve successful delivery and deployment of all DCB to the target lesion as described per the Instructions for Use (IFU) within 3 minutes of insertion without removal and use of an additional device.	Within 3 minutes of insertion of DCB
Target Vessel Patency	Target Vessel Patency is a binary composite endpoint comprised of: CEC adjudicated absence of clinically driven repeat procedure performed for ≥50% stenosis confirmed by angiography within all or part of the target lesion after documentation of recurrent clinical symptoms of PAD following clinical trial treatment procedure (i.e. clinically-driven TLR) occurring at any time-point on, or prior to the 6-month visit date and,; a Duplex Ultrasound Core Lab assessed PSVR value of ≤2.4 (or equivalent by visual assessment if the lesion is non-patent and the PSVR cannot be numerically calculated). The vessel is considered patent if both criteria are met at the time of assessment.	Up to 6 months
Rate of Severe Angiographic Complications	Rate of severe angiographic complications defined as severe dissections (D-F), perforation, or distal emboli requiring additional treatment during the procedure [CEC adjudicated]	At the end of the procedure
Acute Procedural Success	Acute procedural success is defined as both acute technical success and absence of death, stroke, myocardial infarction (MI), acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and/or need for urgent/emergent vascular surgery within 72 hours of the clinical trial treatment [CEC adjudicated].	72 hours after index procedure
Rate of Major Adverse Event (MAE)	Major Adverse Event (MAE) rate at 30 days and 6 months (CEC adjudicated) was defined as: All-cause death through 30 days or; Major amputation of the target limb or; Clinically-driven TLR	30 days and 6 months
Change of Rutherford Classification (ITT Population)	Rutherford Classification; Class 0: Asymptomatic; no hemodynamically significant occlusive disease. Class 1: Mild Claudication; there is no limitation with ordinary physical activities (e.g., walking several blocks, climbing stairs). Limiting symptoms may occur with marked exertion (e.g., strenuous, rapid or prolonged exertion at work or recreation). Class 2: Moderate Claudication; there is a slight limitation of ordinary physical activities (e.g., walking uphill, or more than two level blocks, or climbing stairs rapidly). Subject is comfortable at rest. Class 3: Severe Claudication; there is marked limitation of ordinary physical activities (e.g., walking 1-2 level blocks or climbing one flight of stairs). Subject is comfortable at rest. Class 4: Ischemic rest pain. Class 5: Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia. Class 6: Major tissue loss extending above transmetatarsal level; functional foot no longer salvageable.	Baseline, 30 days and 6 months
Change of Rutherford Classification (mITT Population)	Rutherford Classification; Class 0: Asymptomatic; no hemodynamically significant occlusive disease. Class 1: Mild Claudication; there is no limitation with ordinary physical activities (e.g., walking several blocks, climbing stairs). Limiting symptoms may occur with marked exertion (e.g., strenuous, rapid or prolonged exertion at work or recreation). Class 2: Moderate Claudication; there is a slight limitation of ordinary physical activities (e.g., walking uphill, or more than two level blocks, or climbing stairs rapidly). Subject is comfortable at rest. Class 3: Severe Claudication; there is marked limitation of ordinary physical activities (e.g., walking 1-2 level blocks or climbing one flight of stairs). Subject is comfortable at rest. Class 4: Ischemic rest pain. Class 5: Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia. Class 6: Major tissue loss extending above transmetatarsal level; functional foot no longer salvageable.	Baseline, 30 days and 6 months
Change in Ankle Brachial Index (ABI)	The Ankle-Brachial Index (ABI) is a simple, non-invasive test used to assess peripheral artery disease (PAD). It compares the blood pressure measured at the ankle with the blood pressure measured at the arm (brachial artery).	Baseline (within 30 days of the clinical treatment), and Post Procedure (after the clinical trial treatment prior to discharge: post procedure ABI was collected on average 1.1 days post clinical trial treatment)

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Collaborators: ICON plc
• Investigators: Principal Investigator: Hiroyoshi Yokoi, MD, International University of Health and Welfare, Japan

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): October 10, 2024

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 (Estimated): October 27, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: superficial femoral artery; popliteal artery; de novo lesions
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
• 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