Feasibility Clinical Trial of the Cardio Flow Orbital Atherectomy System to Treat Peripheral Artery Disease (PAD)

NACompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

January 25, 2018

Primary Completion Date

February 22, 2018

Study Completion Date

November 6, 2018

Conditions
Peripheral Arterial Disease
Interventions
DEVICE

Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment

Occlusive lesions will be treated using atherectomy with or without adjunctive low pressure balloon angioplasty.

DEVICE

Balloon Angioplasty

Low pressure balloon angioplasty may be used following atherectomy

Trial Locations (2)

32605

Cardiovascular Research of North Florida, LLC, Gainesville

48080

Eastlake Cardiovascular, PC, Saint Clair Shores

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Libra Medical

OTHER

lead

Cardio Flow, Inc.

INDUSTRY