Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy

NCT ID: NCT05529472

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2024-10-10

Brief Summary

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.

Conditions

Peripheral Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Peripheral Orbital Atherectomy System (OAS)

Intervention Type: DEVICE

Treatment with Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA), pre-dilation and Drug Coated Balloon (DCB) - Medtronic IN.PACT™ Admiral™

Interventions

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™

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ICON plc

INDUSTRY

Sponsor Role: collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hiroyoshi Yokoi, MD

Role: PRINCIPAL_INVESTIGATOR

International University of Health and Welfare, Japan

Locations

Tokyo bay Ichikawa

Urayasu, Chiba, Japan

Matsuyama Red Cross

Matsuyama, Ehime, Japan

Fukuoka Sannou

Sawara, Fukuoka, Japan

Iwaki-City Medical Center

Iwaki, Fukushima, Japan

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Kyoto Katsura Hospital

Nishikyo-ku, Kyoto, Japan

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Nara Medical University

Kashihara, Nara, Japan

Morinomiya

Joto, Osaka, Japan

Ageo Central Hospital

Ageo, Saitama, Japan

Kasukabe Central (Chu-o-)

Kasukabe, Saitama, Japan

Daini Osaka Police Hospital

Osaka, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CLN-0013-P

Identifier Type: -

Identifier Source: org_study_id