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Completed

NCT Number: NCT02752802

DyeVert System RCT

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.

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Key information

Conditions

Coronary Angiography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Schleswig-Holstein

Lübeck, 23538, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Diagnostic Coronary Angiogram

Device

Diagnostic angiographic procedure with the use of the DyeVert System.

Primary outcomes

  1. Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group.

    Time frame: 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 outcomes

  1. Assessment of the Quality of Angiographic Images Between Groups

    Time frame: 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.

  2. Assessment of Incidence of Serious Adverse Device Effect for Subjects Treated With the DyeVert System During the Procedure.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Osprey Medical, Inc

Industry

Registry information

Official study title

Single Site Randomized Control Trial Evaluating the DyeVert System

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 27, 2016
Registry last updated
Feb 28, 2017

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.

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