DyeVert System RCT

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the amount of contrast media (CM) saved using the DyeVert system in diagnostic angiographic procedures compared to a control group.

Detailed Description
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This is a prospective, randomized, parallel group, single center clinical evaluation of the DyeVert System. Subjects undergoing a diagnostic coronary angiogram procedure with a 5 French catheter are eligible to participate in this study. The treatment group will use the DyeVert System. The trial will be conducted at one center, located in Germany. A sample size of 96 evaluable subjects will provide a sufficient number of samples to evaluate the primary objectives. Randomization will occur following confirmation that the subject meets the inclusion/exclusion criteria and has signed an informed consent. Subjects that are anticipated to be a diagnostic only procedure, but end up being an ad-hoc PCI, can still remain enrolled in the trial. If a subject proceeds to a PCI, data will only be collected through the diagnostic portion of the case.

Official Title
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Single Site Randomized Control Trial Evaluating the DyeVert System

Conditions
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Coronary Angiography

Intervention / Treatment
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* Device: Diagnostic Coronary Angiogram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is indicated for a diagnostic coronary angiogram procedure with a 5 French catheter only. The subject is ≥ 18 years of age The subject is willing and able to provide appropriate informed consent. Exclusion Criteria: Subject is undergoing a STEMI procedure Subject has previously been diagnosed with anomalous coronary anatomy Subject has previously underwent coronary artery bypass grafting Subject has severe peripheral artery disease at access site Subject is having a staged PCI The subject is female and currently pregnant In the investigator's opinion, the subject is not considered to be a suitable candidate

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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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system. | Device: Diagnostic Coronary Angiogram<br>* Diagnostic angiographic procedure with the use of the DyeVert System.<br>|
| Active Comparator: Control<br>The control group will include standard of care for diagnostic coronary angiograms. | Device: Diagnostic Coronary Angiogram<br>* Diagnostic angiographic procedure with the use of the DyeVert System.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group. | DyeVert is intended to reduce the total amount of contrast media (CM) administered during procedures requiring the injection of contrast media. Clinical evidence has demonstrated that CM can be toxic to the kidneys, leading to contrast induced nephropathy (CIN) | All data will be collected on the day of the procedure, over an average of 12 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the Quality of Angiographic Images Between Groups | To assess the adequacy of the image quality. The proportion of images in which contrast opacification is deemed sufficient to evaluate the desired anatomical structures adequately will be compared between the DyeVert and control groups. | AlAll data will be collected on the day of the procedure, over an average of 12 hours. | 
| Assessment of Incidence of Serious Adverse Device Effect for Subjects Treated With the DyeVert System During the Procedure. | To assess the incidence of Serious Adverse Device Effect for subjects treated with the DyeVert System during the procedure for treatment subjects only. | All data will be collected on the day of the procedure, over an average of 12 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast Media, Angiography