DyeVert™ Plus Contrast Reduction System Multicenter Observational Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-03-30

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.

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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DyeVert Plus Contrast Reduction System

Intervention Type 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.

Interventions

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DyeVert Plus Contrast Reduction System

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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No