DyeVert™ Plus Contrast Reduction System Multicenter Observational Study

Completed

Conditions studied: Chronic Kidney Disease

In brief

This is a prospective, single arm, multi-center, observational clinical study of the DyeVert Plus System. The DyeVert Plus System is an FDA-cleared device designed to reduce contrast media volume delivered during angiography and permit real-time contrast media volume monitoring.

Key facts

Study ID

NCT03715452

Run by

Osprey Medical, Inc

People needed

114

Starts

2017-07-01

Expected to finish

2018-03-30

Last updated by the study team

2020-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Scheduled to undergo CAG and/or PCI
• Baseline estimated glomerular filtration rate (eGFR) of ≥20 and ≤60 mL/ min/1.73 m2

You may not qualify if…

• Acute ST-elevation myocardial infarction or known coronary artery fistulas
• Body mass index (BMI) >40
• Currently pregnant
• Undergoing a chronic total occlusion procedure or optical coherence tomography analysis
• Planning to undergo transcatheter aortic valve replacement within 72 hr of the index procedure
• A condition known to require large volumes of contrast (>10 mL) for each injection

Where it is running

• Harbor UCLA Medical Center — Torrance, California, United States
• Atlanta VA Medical Center, Emory University School of Medicine — Atlanta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• North Mississippi Medical Center — Tupelo, Mississippi, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• WakeMed Heart and Vascular — Raleigh, North Carolina, United States
• Christ Hospital, Heart and Vascular Center, Lindner Research Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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