Trial Outcomes & Findings for DyeVert™ Plus Contrast Reduction System Multicenter Observational Study (NCT NCT03715452)
NCT ID: NCT03715452
Last Updated: 2020-10-19
Results Overview
The percentage of contrast media volume saved (diverted) over the total procedure as reported on the DyeVert Plus display at the end of each case.
Recruitment status
COMPLETED
Target enrollment
114 participants
Primary outcome timeframe
At the time of the coronary angiography (CAG) or percutaneous coronary interventional (PCI) procedure
Results posted on
2020-10-19
Participant Flow
Participant milestones
| Measure |
DyeVert™ Plus Contrast Reduction System
DyeVert Plus Contrast Reduction System
The DyeVert Plus System interfaces with standard manifold systems to provide real-time contrast monitoring and reduce the amount of contrast used in catheterization procedures while maintaining fluoroscopic image quality. System components include a disposable, single-use, sterile DyeVert Plus Disposable Kit that contains a Smart Syringe and DyeVert Plus Module, which is connected to a standard manifold and provides fluid pathway resistance modulation via a dedicated diversion valve. The diversion valve self-adjusts to the manual injection pressure to divert some of the contrast media into the reservoir chamber within the module. This diverted volume of contrast media does not enter the patient.
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|---|---|
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Overall Study
STARTED
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114
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Overall Study
COMPLETED
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114
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DyeVert™ Plus Contrast Reduction System Multicenter Observational Study
Baseline characteristics by cohort
| Measure |
DyeVert™ Plus Contrast Reduction System
n=114 Participants
Dyevert™ Plus Contrast Reduction System
DyeVert Plus Contrast Reduction System: The DyeVert Plus System interfaces with standard manifold systems to provide real-time contrast monitoring and reduce the amount of contrast used in catheterization procedures while maintaining fluoroscopic image quality. System components include a disposable, single-use, sterile DyeVert Plus Disposable Kit that contains a Smart Syringe and DyeVert Plus Module, which is connected to a standard manifold and provides fluid pathway resistance modulation via a dedicated diversion valve. The diversion valve self-adjusts to the manual injection pressure to divert some of the contrast media into the reservoir chamber within the module. This diverted volume of contrast media does not enter the patient.
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|---|---|
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Age, Continuous
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72 years
STANDARD_DEVIATION 9 • n=5 Participants
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Sex: Female, Male
Female
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32 Participants
n=5 Participants
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Sex: Female, Male
Male
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82 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race · Caucasian
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86 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Race · African American
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25 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race · Other
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3 Participants
n=5 Participants
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Region of Enrollment
United States
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114 Participants
n=5 Participants
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Estimated glomerular filtration rate (eGFR)
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43 mL/min/1.73m2
STANDARD_DEVIATION 11 • n=5 Participants
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Serum creatinine (mg/dL)
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1.6 mg/dL
STANDARD_DEVIATION 0.5 • n=5 Participants
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Body mass index (BMI)
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29 kg/m2
STANDARD_DEVIATION 5 • n=5 Participants
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Comorbidities
Hypertension
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110 participants
n=5 Participants
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Comorbidities
Coronary artery disease
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86 participants
n=5 Participants
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Comorbidities
Prior PCI
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60 participants
n=5 Participants
|
|
Comorbidities
Diabetes
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60 participants
n=5 Participants
|
|
Comorbidities
Congestive heart failure
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54 participants
n=5 Participants
|
|
Comorbidities
Prior myocardial infarction
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39 participants
n=5 Participants
|
|
Comorbidities
Anemia
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33 participants
n=5 Participants
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Comorbidities
Angina
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30 participants
n=5 Participants
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Procedure type
CAG only
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74 Participants
n=5 Participants
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Procedure type
CAG+PCI
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30 Participants
n=5 Participants
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Procedure type
PCI only
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10 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: At the time of the coronary angiography (CAG) or percutaneous coronary interventional (PCI) procedureThe percentage of contrast media volume saved (diverted) over the total procedure as reported on the DyeVert Plus display at the end of each case.
Outcome measures
| Measure |
DyeVert Plus Contrast Reduction System
n=105 Participants
DyeVert Plus Contrast Reduction System
DyeVert Plus Contrast Reduction System: The DyeVert Plus System interfaces with standard manifold systems to provide real-time contrast monitoring and reduce the amount of contrast used in catheterization procedures while maintaining fluoroscopic image quality. System components include a disposable, single-use, sterile DyeVert Plus Disposable Kit that contains a Smart Syringe and DyeVert Plus Module, which is connected to a standard manifold and provides fluid pathway resistance modulation via a dedicated diversion valve. The diversion valve self-adjusts to the manual injection pressure to divert some of the contrast media into the reservoir chamber within the module. This diverted volume of contrast media does not enter the patient.
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|---|---|
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Percentage of Contrast Media Volume Saved
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40.1 % CMV savings per procedure
Interval 38.4 to 41.8
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SECONDARY outcome
Timeframe: From the time of the procedure through discharge (from the index procedure, approximately 0 - 3 days)An adverse event is defined as "any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device." DyeVert Plus System-related adverse events will be collected. Additionally, contrast media-related adverse events, such as acute kidney injury and anaphylactic shock, will be collected.
Outcome measures
| Measure |
DyeVert Plus Contrast Reduction System
n=114 Participants
DyeVert Plus Contrast Reduction System
DyeVert Plus Contrast Reduction System: The DyeVert Plus System interfaces with standard manifold systems to provide real-time contrast monitoring and reduce the amount of contrast used in catheterization procedures while maintaining fluoroscopic image quality. System components include a disposable, single-use, sterile DyeVert Plus Disposable Kit that contains a Smart Syringe and DyeVert Plus Module, which is connected to a standard manifold and provides fluid pathway resistance modulation via a dedicated diversion valve. The diversion valve self-adjusts to the manual injection pressure to divert some of the contrast media into the reservoir chamber within the module. This diverted volume of contrast media does not enter the patient.
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|---|---|
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Evaluation of Adverse Events Through Discharge (From the Index Procedure)
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11 Participants
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Adverse Events
DyeVert Plus Contrast Reduction System
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DyeVert Plus Contrast Reduction System
n=114 participants at risk
DyeVert Plus Contrast Reduction System
DyeVert Plus Contrast Reduction System: The DyeVert Plus System interfaces with standard manifold systems to provide real-time contrast monitoring and reduce the amount of contrast used in catheterization procedures while maintaining fluoroscopic image quality. System components include a disposable, single-use, sterile DyeVert Plus Disposable Kit that contains a Smart Syringe and DyeVert Plus Module, which is connected to a standard manifold and provides fluid pathway resistance modulation via a dedicated diversion valve. The diversion valve self-adjusts to the manual injection pressure to divert some of the contrast media into the reservoir chamber within the module. This diverted volume of contrast media does not enter the patient.
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|---|---|
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Product Issues
DyeVert Plus System-Related Events
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0.00%
0/114 • Procedure through discharge.
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Renal and urinary disorders
Acute Kidney Injury
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9.6%
11/114 • Number of events 11 • Procedure through discharge.
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Immune system disorders
Contrast-Related Anaphylactic Shock
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0.00%
0/114 • Procedure through discharge.
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Additional Information
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