Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy

NCT05529472 | Completed Results DMC FDA Device

• 1 other identifier: CLN-0013-P
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 12

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

Keywords

superficial femoral artery; popliteal artery; de novo lesions

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Acute Device Success

  The percentage of subjects with the following, post-procedure: 1. ≤50% residual stenosis post OAD + POBA \[Angiographic Core Lab assessed\] and, 2. 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 Outcomes (10)

• Change in Lesion Stenosis

  Baseline, Post OAD, Post POBA

• Acute Technical Success

  At the end of the procedure

• Drug Coated Balloon (DCB) Device Success

  Within 3 minutes of insertion of DCB

• Target Vessel Patency

  Up to 6 months

• Rate of Severe Angiographic Complications

  At the end of the procedure

Study Arms (1)

Peripheral Orbital Atherectomy System (OAS)

EXPERIMENTAL

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)

Interventions

Peripheral Orbital Atherectomy System (OAS) 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™

Peripheral Orbital Atherectomy System (OAS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead
• ICON plc: collaborator

Study Sites (12)

Tokyo bay Ichikawa

Urayasu, Chiba, Japan

Location

Matsuyama Red Cross

Matsuyama, Ehime, Japan

Location

Fukuoka Sannou

Sawara, Fukuoka, Japan

Location

Iwaki-City Medical Center

Iwaki, Fukushima, Japan

Location

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Location

Kyoto Katsura Hospital

Nishikyo-ku, Kyoto, Japan

Location

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Location

Nara Medical University

Kashihara, Nara, Japan

Location

Morinomiya

Joto, Osaka, Japan

Location

Ageo Central Hospital

Ageo, Saitama, Japan

Location

Kasukabe Central (Chu-o-)

Kasukabe, Saitama, Japan

Location

Daini Osaka Police Hospital

Osaka, Japan

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Ikuko Kishimoto, Principal Clinical Scientist
• Organization: Abbott Vascular

ikuko.kishimoto@abbott.com

651.756.4878

Study Officials

• Hiroyoshi Yokoi, MD

  International University of Health and Welfare, Japan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 7, 2022
• Study Start: January 10, 2023
• Primary Completion: April 1, 2024
• Study Completion: October 10, 2024
• Last Updated: October 27, 2025
• Results First Posted: October 27, 2025

Record last verified: 2025-09

Locations

JP (12)