Coronary Angiography
Conditions
Brief summary
The purpose of this study is to evaluate the usability characteristics of DyeVert™ during normal clinical use and to understand the amount of contrast media (CM) diverted from the subject and saved over a total angiographic procedure.
Interventions
DEVICECoronary Angiography
The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases.
Sponsors
Osprey Medical, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject is indicated for a coronary angiogram or percutaneous coronary procedure 2. The subject is ≥ 18 years of age 3. The subject (or subject's legal representative) is willing and able to provide appropriate informed consent.
Exclusion criteria
1. Subject is undergoing a STEMI procedure 2. The subject is female and currently pregnant 3. In the investigator's opinion, the subject is not considered to be a suitable candidate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure | 1 Day | The subject is exited from the study once they are discharged. |
Countries
Australia, Germany
Participant flow
Recruitment details
First Enrollment on 10/26/2015, Last Enrollment on 11/19/2015
Pre-assignment details
Subjects undergoing a coronary artery imaging (angiogram) for diagnostic or percutaneous coronary intervention (PCI) procedures are eligible to participate in this study. All data will be collected on the day of the procedure. There are no follow-up visits in this study.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm All subjects enrolled in the trial will use the DyeVert System.
Coronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases. | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Treatment Arm |
|---|---|
| Age, Continuous | 69.3 years STANDARD_DEVIATION 10.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 37 Participants |
| Region of Enrollment Australia | 20 participants |
| Region of Enrollment Germany | 24 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 |
Outcome results
Primary
Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure
The subject is exited from the study once they are discharged.
Time frame: 1 Day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure | 47.4 percent of contrast media saved | Standard Deviation 8.7 |