DyeVert™ Plus Contrast Reduction System Multicenter Observational Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Minimizing Radiographic Contrast Administration During Coronary Angiography Using a Novel Contrast Reduction System: A Multicenter Observational Study of the DyeVert™ Plus Contrast Reduction System

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Device: DyeVert Plus Contrast Reduction System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DyeVert Plus Contrast Reduction System<br>DyeVert Plus Contrast Reduction System | Device: DyeVert Plus Contrast Reduction System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Contrast Media Volume Saved | The percentage of contrast media volume saved (diverted) over the total procedure as reported on the DyeVert Plus display at the end of each case. | At the time of the coronary angiography (CAG) or percutaneous coronary interventional (PCI) procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Adverse Events Through Discharge (From the Index Procedure) | An adverse event is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device. DyeVert Plus System-related adverse events will be collected. Additionally, contrast media-related adverse events, such as acute kidney injury and anaphylactic shock, will be collected. | From the time of the procedure through discharge (from the index procedure, approximately 0 - 3 days) |