DyeVert™ Plus Contrast Reduction System Multicenter Observational Study

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.

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.

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