DyeVert™ Plus Contrast Reduction System Multicenter Observational Study
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/25/2018 |
| Start Date: | July 1, 2017 |
| End Date: | March 30, 2018 |
Minimizing Radiographic Contrast Administration During Coronary Angiography Using a Novel Contrast Reduction System: A Multicenter Observational Study of the DyeVert™ Plus Contrast Reduction System
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.
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.
The purpose of this observational study is to evaluate the amount of contrast media saved
using DyeVert Plus in coronary angiographic and/or interventional procedures performed with
manual injection and evaluate the impact of predetermined thresholds and real-time
monitoring.
using DyeVert Plus in coronary angiographic and/or interventional procedures performed with
manual injection and evaluate the impact of predetermined thresholds and real-time
monitoring.
Inclusion Criteria:
- Scheduled to undergo CAG and/or PCI
- Baseline estimated glomerular filtration rate (eGFR) of ≥20 and ≤60 mL/ min/1.73 m2
Exclusion Criteria:
- Acute ST-elevation myocardial infarction or known coronary artery fistulas
- Body mass index >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
We found this trial at
8
sites
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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