Chronic Kidney Disease
Conditions
Brief summary
This is a prospective, single arm, multi-center, observational clinical study of the DyeVert Plus System. The DyeVert Plus System is an FDA-cleared device designed to reduce contrast media volume delivered during angiography and permit real-time contrast media volume monitoring.
Detailed description
The purpose of this observational study is to evaluate the amount of contrast media saved using DyeVert Plus in coronary angiographic and/or interventional procedures performed with manual injection and evaluate the impact of predetermined thresholds and real-time monitoring.
Interventions
DEVICEDyeVert 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.
Sponsors
Osprey Medical, Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled to undergo CAG and/or PCI * Baseline estimated glomerular filtration rate (eGFR) of ≥20 and ≤60 mL/ min/1.73 m2
Exclusion criteria
* Acute ST-elevation myocardial infarction or known coronary artery fistulas * Body mass index (BMI) \>40 * Currently pregnant * Undergoing a chronic total occlusion procedure or optical coherence tomography analysis * Planning to undergo transcatheter aortic valve replacement within 72 hr of the index procedure * A condition known to require large volumes of contrast (\>10 mL) for each injection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Contrast Media Volume Saved | At the time of the coronary angiography (CAG) or percutaneous coronary interventional (PCI) procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Adverse Events Through Discharge (From the Index Procedure) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DyeVert™ Plus Contrast Reduction System 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. | 114 |
| Total | 114 |
Baseline characteristics
| Characteristic | DyeVert™ Plus Contrast Reduction System |
|---|---|
| Age, Continuous | 72 years STANDARD_DEVIATION 9 |
| Body mass index (BMI) | 29 kg/m2 STANDARD_DEVIATION 5 |
| Comorbidities Anemia | 33 participants |
| Comorbidities Angina | 30 participants |
| Comorbidities Congestive heart failure | 54 participants |
| Comorbidities Coronary artery disease | 86 participants |
| Comorbidities Diabetes | 60 participants |
| Comorbidities Hypertension | 110 participants |
| Comorbidities Prior myocardial infarction | 39 participants |
| Comorbidities Prior PCI | 60 participants |
| Estimated glomerular filtration rate (eGFR) | 43 mL/min/1.73m2 STANDARD_DEVIATION 11 |
| Procedure type CAG only | 74 Participants |
| Procedure type CAG+PCI | 30 Participants |
| Procedure type PCI only | 10 Participants |
| Race/Ethnicity, Customized Race African American | 25 Participants |
| Race/Ethnicity, Customized Race Caucasian | 86 Participants |
| Race/Ethnicity, Customized Race Other | 3 Participants |
| Region of Enrollment United States | 114 Participants |
| Serum creatinine (mg/dL) | 1.6 mg/dL STANDARD_DEVIATION 0.5 |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 114 |
| other Total, other adverse events | 11 / 114 |
| serious Total, serious adverse events | 0 / 114 |
Outcome results
Primary
Percentage of Contrast Media Volume Saved
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.
Time frame: At the time of the coronary angiography (CAG) or percutaneous coronary interventional (PCI) procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DyeVert Plus Contrast Reduction System | Percentage of Contrast Media Volume Saved | 40.1 % CMV savings per procedure |
Secondary
Evaluation of Adverse Events Through Discharge (From the Index Procedure)
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.
Time frame: From the time of the procedure through discharge (from the index procedure, approximately 0 - 3 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DyeVert Plus Contrast Reduction System | Evaluation of Adverse Events Through Discharge (From the Index Procedure) | 11 Participants |