DyeVert System RCT

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treatment	Diagnostic Coronary Angiogram	The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.
Control	Diagnostic Coronary Angiogram	The control group will include standard of care for diagnostic coronary angiograms.

Primary Outcome Measures

Name	Time	Method
Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group.	All data will be collected on the day of the procedure, over an average of 12 hours.	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)

Secondary Outcome Measures

Name	Time	Method
Assessment of Incidence of Serious Adverse Device Effect for Subjects Treated With the DyeVert System During the Procedure.	All data will be collected on the day of the procedure, over an average of 12 hours.	To assess the incidence of Serious Adverse Device Effect for subjects treated with the DyeVert System during the procedure for treatment subjects only.
Assessment of the Quality of Angiographic Images Between Groups	AlAll data will be collected on the day of the procedure, over an average of 12 hours.	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.