DyeVert™ Plus Contrast Reduction System Multicenter Observational Study

CompletedOBSERVATIONAL
Enrollment

114

Participants

Timeline

Start Date

July 1, 2017

Primary Completion Date

January 31, 2018

Study Completion Date

March 30, 2018

Conditions
Chronic Kidney Disease
Interventions
DEVICE

DyeVert Plus Contrast Reduction System

The DyeVert Plus System interfaces with standard manifold systems to provide real-time contrast monitoring and reduce the amount of contrast used in catheterization procedures while maintaining fluoroscopic image quality. System components include a disposable, single-use, sterile DyeVert Plus Disposable Kit that contains a Smart Syringe and DyeVert Plus Module, which is connected to a standard manifold and provides fluid pathway resistance modulation via a dedicated diversion valve. The diversion valve self-adjusts to the manual injection pressure to divert some of the contrast media into the reservoir chamber within the module. This diverted volume of contrast media does not enter the patient.

Trial Locations (8)

27518

WakeMed Heart and Vascular, Raleigh

30308

Atlanta VA Medical Center, Emory University School of Medicine, Atlanta

38801

North Mississippi Medical Center, Tupelo

45219

Christ Hospital, Heart and Vascular Center, Lindner Research Center, Cincinnati

48073

William Beaumont Hospital, Royal Oak

60637

University of Chicago Medical Center, Chicago

63110

Washington University School of Medicine, St Louis

90509

Harbor UCLA Medical Center, Torrance

Sponsors
All Listed Sponsors
lead

Osprey Medical, Inc

INDUSTRY