Diamondback in Peripheral Vascular Disease

NATerminatedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

August 8, 2017

Primary Completion Date

May 13, 2019

Study Completion Date

May 13, 2019

Conditions
Peripheral Vascular DiseasesCritical Limb Ischemia
Interventions
DEVICE

Treatment with CSI atherectomy device

Following peripheral angiography, patients with significant SFA or below the knee artery disease (≥ 50%) or total occlusions (100%) will have a baseline OCT imaging of the target vessel and the lesion be treated with proper size CSI burr. Repeat OCT imaging will be performed after CSI. Drug eluting balloon angioplasty may be performed in discretion of the operator. If DEB is used, a final OCT imaging will be performed to assess lesion expansion and possible dissections. Balloon sizing will be based on 1:1 vessel ratio with the length covering from minimally diseased distal segment to minimally diseased proximal segment. We will try to avoid use of stents.

Trial Locations (2)

72211

Arkansas Heart Hospital, Little Rock

Arkansas Site Management Services LLC, Little Rock

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Abbott Medical Devices

INDUSTRY

lead

Arkansas Heart Hospital

OTHER