Trial Outcomes & Findings for DyeVert Pilot Trial (NCT NCT02606734)
NCT ID: NCT02606734
Last Updated: 2016-10-26
Results Overview
The subject is exited from the study once they are discharged.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
1 Day
Results posted on
2016-10-26
Participant Flow
First Enrollment on 10/26/2015, Last Enrollment on 11/19/2015
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DyeVert Pilot Trial
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=44 Participants
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.
|
|---|---|
|
Age, Continuous
|
69.3 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 DayThe subject is exited from the study once they are discharged.
Outcome measures
| Measure |
Treatment Arm
n=44 Participants
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.
|
|---|---|
|
Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure
|
47.4 percent of contrast media saved
Standard Deviation 8.7
|
Adverse Events
Treatment Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place