Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy

NACompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

January 10, 2023

Primary Completion Date

April 1, 2024

Study Completion Date

October 10, 2024

Conditions
Peripheral Artery Disease
Interventions
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™

Trial Locations (12)

Unknown

Tokyo bay Ichikawa, Urayasu

Matsuyama Red Cross, Matsuyama

Fukuoka Sannou, Sawara

Iwaki-City Medical Center, Iwaki

Shonan Kamakura General Hospital, Kamakura

Kyoto Katsura Hospital, Nishikyo-ku

Sendai Kousei Hospital, Sendai

Nara Medical University, Kashihara

Morinomiya, Joto

Ageo Central Hospital, Ageo

Kasukabe Central (Chu-o-), Kasukabe

Daini Osaka Police Hospital, Osaka

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

ICON plc

INDUSTRY

lead

Abbott Medical Devices

INDUSTRY