Coronary Angiography
Conditions
Keywords
Contrast Media, Angiography
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.
Interventions
DEVICEDiagnostic Coronary Angiogram
Diagnostic angiographic procedure with the use of the DyeVert System.
Sponsors
Osprey Medical, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject is indicated for a diagnostic coronary angiogram procedure with a 5 French catheter only. 2. The subject is ≥ 18 years of age 3. The subject is willing and able to provide appropriate informed consent.
Exclusion criteria
1. Subject is undergoing a STEMI procedure 2. Subject has previously been diagnosed with anomalous coronary anatomy 3. Subject has previously underwent coronary artery bypass grafting 4. Subject has severe peripheral artery disease at access site 5. Subject is having a staged PCI 6. The subject is female and currently pregnant 7. In the investigator's opinion, the subject is not considered to be a suitable candidate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.
Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System. | 48 |
| Control The control group will include standard of care for diagnostic coronary angiograms.
Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System. | 48 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Contrast Volume Not Collected | 1 | 0 |
Baseline characteristics
| Characteristic | Treatment | Control | Total |
|---|---|---|---|
| Age, Continuous | 68.6 years STANDARD_DEVIATION 13.6 | 66.2 years STANDARD_DEVIATION 12.8 | 67.4 years STANDARD_DEVIATION 13.2 |
| Gender Female | 20 Participants | 20 Participants | 40 Participants |
| Gender Male | 28 Participants | 28 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 48 | 3 / 48 |
| serious Total, serious adverse events | 2 / 48 | 4 / 48 |
Outcome results
Primary
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)
Time frame: All data will be collected on the day of the procedure, over an average of 12 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group. | 38.0 ml | Standard Deviation 13.1 |
| Control | Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group. | 62.5 ml | Standard Deviation 12.7 |
Secondary
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.
Time frame: All data will be collected on the day of the procedure, over an average of 12 hours.
Population: Only treatments subjects were analyzed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Assessment of Incidence of Serious Adverse Device Effect for Subjects Treated With the DyeVert System During the Procedure. | 0 Number of Events |
Secondary
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.
Time frame: AlAll data will be collected on the day of the procedure, over an average of 12 hours.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Treatment | Assessment of the Quality of Angiographic Images Between Groups | 379 Images |
| Control | Assessment of the Quality of Angiographic Images Between Groups | 386 Images |