Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy

Not Applicable

Completed

• Conditions: Peripheral Artery Disease
• Interventions: Device: Peripheral Orbital Atherectomy System (OAS)

• Registration Number: NCT05529472
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-02
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-07
• Study Start: 2023-01-10
• Primary Completion: 2024-04-01
• Study Completion: 2024-10-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peripheral Orbital Atherectomy System (OAS)	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)

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects with Acute Device Success	Immediate post-procedure	Post-procedure acute device success

Secondary Outcome Measures

Name	Time	Method
Target Vessel Patency	6 months	Target Vessel Patency at 6 months post-procedure

Trial Locations

Locations (12)

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-city, 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

Daini Osaka Police Hospital; 🇯🇵 Osaka, Japan

Ageo Central Hospital; 🇯🇵 Ageo, Saitama, Japan

Kasukabe Central (Chu-o-); 🇯🇵 Kasukabe, Saitama, Japan