DyeVert™ Plus Contrast Reduction System Multicenter Observational Study

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Harbor UCLA Medical Center, Torrance, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DyeVert Plus Contrast Reduction System

Device

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.

Primary outcomes

Percentage of Contrast Media Volume Saved

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

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.

Secondary outcomes

Evaluation of Adverse Events Through Discharge (From the Index Procedure)

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

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.

Sponsors and collaborators

Lead sponsor

Osprey Medical, Inc

Industry

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Oct 23, 2018
Registry last updated: Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed