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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DyeVert Plus Contrast Reduction System | DyeVert Plus Contrast Reduction System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DyeVert Plus Contrast Reduction System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the time of the coronary angiography (CAG) or percutaneous coronary interventional (PCI) procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult subjects undergoing diagnostic coronary angiography (CAG) and/or percutaneous coronary interventional (PCI) procedures performed with manual injections
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbor UCLA Medical Center | Torrance | California | 90509 | United States | ||
| Atlanta VA Medical Center, Emory University School of Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | % CMV savings per procedure | At the time of the coronary angiography (CAG) or percutaneous coronary interventional (PCI) procedure |
|
Procedure through discharge.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DyeVert Plus System-Related Events | Product Issues | Systematic Assessment | Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, related to the DyeVert Plus System |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President of Clinical Affairs | Osprey Medical, Inc. | 952.955.8236 | kknish@ospreymed.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2017 | Oct 1, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| From the time of the procedure through discharge (from the index procedure, approximately 0 - 3 days) |
| Atlanta |
| Georgia |
| 30308 |
| United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| WakeMed Heart and Vascular | Raleigh | North Carolina | 27518 | United States |
| Christ Hospital, Heart and Vascular Center, Lindner Research Center | Cincinnati | Ohio | 45219 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Estimated glomerular filtration rate (eGFR) | Mean | Standard Deviation | mL/min/1.73m2 |
|
| Serum creatinine (mg/dL) | Mean | Standard Deviation | mg/dL |
|
| Body mass index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| Comorbidities | Number | participants |
|
| Procedure type | Count of Participants | Participants |
|
|
|
| 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. | Posted | Count of Participants | Participants | From the time of the procedure through discharge (from the index procedure, approximately 0 - 3 days) |
|
|
|
| 0 |
| 114 |
| 0 |
| 114 |
| 11 |
| 114 |
|
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment | Acute kidney injury events were defined as a >0.3 mg/dL increase in serum creatinine post-procedure through discharge compared to the baseline value or through the date of, but prior to, a secondary procedure for staged procedures. |
|
| Contrast-Related Anaphylactic Shock | Immune system disorders | Systematic Assessment | Based on clinical judgement |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |