N/A
Completed N=114
DyeVert™ Plus Contrast Reduction System Multicenter Observational Study
Source: ClinicalTrials.gov NCT03715452 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Percentage of Contrast Media Volume Saved — 40.1 % CMV savings per procedure
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Contrast Media Volume Saved |
40.1 | — |
| SECONDARY Evaluation of Adverse Events Through Discharge (From the Index Procedure) |
11 | — |
Eligibility Criteria
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 (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
Data sourced from ClinicalTrials.gov (NCT03715452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.