Directional Versus Orbital Atherectomy Plaque Modification and Luminal Area Assessment of the Femoro-popliteal Artery Via Intravascular Ultrasound

NACompletedINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

March 23, 2018

Primary Completion Date

August 21, 2023

Study Completion Date

August 31, 2023

Conditions
Peripheral Artery Disease
Interventions
DEVICE

Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS

"Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is a small catheter with a diamond crown. The doctor inserts it at the groin and advances into the leg.The OAS works by spinning around inside the artery to sand down the buildup of material along the artery walls while leaving the healthy vessel behind."

DEVICE

Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS device

HawkOne Directional Atherectomy System (DAS) also is the small catheter with cutting device. Doctor slowly and smoothly advances it across the blockage in your artery and shaves the plaque from the vessel wall and collects it in the reservoir.

Trial Locations (1)

10016

New York University School of Medicine, New York

All Listed Sponsors
lead

NYU Langone Health

OTHER

NCT03495453 - Directional Versus Orbital Atherectomy Plaque Modification and Luminal Area Assessment of the Femoro-popliteal Artery Via Intravascular Ultrasound | Biotech Hunter | Biotech Hunter