Evaluation of the FreedomFlow™ Orbital Atherectomy System to Treat Peripheral Artery Disease

NACompletedINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

December 17, 2018

Primary Completion Date

March 24, 2021

Study Completion Date

October 13, 2021

Conditions
Peripheral Arterial Disease
Interventions
DEVICE

Orbital Circumferential Atherectomy

Remove atherosclerotic plaque and modify vessel wall compliance within peripheral arterial vessels. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

Trial Locations (13)

32256

First Coast Cardiovascular Institute, Jacksonville

32605

Cardiovascular Research of North Florida, LLC, Gainesville

32714

Orlando Heart and Vascular Institute, Altamonte Springs

33312

Palm Vascular Center of Broward, LLC, Fort Lauderdale

33410

Cardiology Partners Clinical Research Institute, Palm Beach Gardens

48080

Eastlake Cardiovascular, PC, Saint Clair Shores

49525

Advanced Cardiac & Vascular Centers for Amputation Prevention, Grand Rapids

70360

Cardiovascular Institute of the South, Houma

70570

Cardiovascular Institute of the South, Opelousas

75702

Cardiovascular Associates of East Texas, Tyler

77505

Orion Medical Research, LLC, Pasadena

78756

Cardiothoracic and Vascular Surgeons, Austin

79430

Texas Tech University Medical Center, Lubbock

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Libra Medical

OTHER

lead

Cardio Flow, Inc.

INDUSTRY