DyeVert™ Plus Contrast Reduction System Multicenter Observational Study

Osprey Medical, Inc114 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

114

Conditions

Chronic Kidney Disease

Interventions

DyeVert Plus Contrast Reduction SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

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

Outcomes

Primary Outcomes

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.

Time frame: At the time of the coronary angiography (CAG) or percutaneous coronary interventional (PCI) procedure

Secondary Outcomes

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.

Time frame: From the time of the procedure through discharge (from the index procedure, approximately 0 - 3 days)

Data from ClinicalTrials.gov

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