Trial Outcomes & Findings for DyeVert System RCT (NCT NCT02752802)
NCT ID: NCT02752802
Last Updated: 2017-02-28
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
96 participants
Primary outcome timeframe
All data will be collected on the day of the procedure, over an average of 12 hours.
Results posted on
2017-02-28
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
48
|
|
Overall Study
COMPLETED
|
47
|
48
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Contrast Volume Not Collected
|
1
|
0
|
Baseline Characteristics
DyeVert System RCT
Baseline characteristics by cohort
| Measure |
Treatment
n=48 Participants
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.
|
Control
n=48 Participants
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.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.6 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
66.2 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
67.4 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Gender
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Gender
Male
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Treatment
n=47 Participants
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.
|
Control
n=48 Participants
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.
|
|---|---|---|
|
Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group.
|
38.0 ml
Standard Deviation 13.1
|
62.5 ml
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Treatment
n=399 Images
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.
|
Control
n=404 Images
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.
|
|---|---|---|
|
Assessment of the Quality of Angiographic Images Between Groups
|
379 Images
|
386 Images
|
SECONDARY outcome
Timeframe: 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.
To assess the incidence of Serious Adverse Device Effect for subjects treated with the DyeVert System during the procedure for treatment subjects only.
Outcome measures
| Measure |
Treatment
n=48 Participants
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.
|
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.
|
|---|---|---|
|
Assessment of Incidence of Serious Adverse Device Effect for Subjects Treated With the DyeVert System During the Procedure.
|
0 Number of Events
|
—
|
Adverse Events
Treatment
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Control
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=48 participants at risk
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.
|
Control
n=48 participants at risk
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.
|
|---|---|---|
|
General disorders
Extended Hospital Stay
|
4.2%
2/48 • Number of events 2 • At point of discharge from index procedure, approximetly 12 hours.
|
4.2%
2/48 • Number of events 2 • At point of discharge from index procedure, approximetly 12 hours.
|
|
General disorders
Death
|
0.00%
0/48 • At point of discharge from index procedure, approximetly 12 hours.
|
4.2%
2/48 • Number of events 2 • At point of discharge from index procedure, approximetly 12 hours.
|
Other adverse events
| Measure |
Treatment
n=48 participants at risk
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.
|
Control
n=48 participants at risk
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.
|
|---|---|---|
|
General disorders
General Adverse Events
|
4.2%
2/48 • Number of events 3 • At point of discharge from index procedure, approximetly 12 hours.
|
6.2%
3/48 • Number of events 3 • At point of discharge from index procedure, approximetly 12 hours.
|
Additional Information
Michele Shepard, Vice President of Clinical Affairs
Osprey Medical, Inc
Phone: 952-955-8236
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place