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The purpose of this study is to evaluate the usability characteristics of DyeVert™ during normal clinical use and to understand the amount of contrast media (CM) diverted from the subject and saved over a total angiographic procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Other | All subjects enrolled in the trial will use the DyeVert System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary Angiography | Device | The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure | The subject is exited from the study once they are discharged. | 1 Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monash Health | Clayton | Victoria | 3168 | Australia | ||
| University Hospital of Schleswig-Holstein |
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.
First Enrollment on 10/26/2015, Last Enrollment on 11/19/2015
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure | The subject is exited from the study once they are discharged. | Posted | Mean | Standard Deviation | percent of contrast media saved | 1 Day |
|
|
AE Reporting occurred through the subjects discharge from the index procedure.
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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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michele Shepard | Osprey Medical | 952-955-5236 | mshepard@ospreymed.com |
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| ID | Term |
|---|---|
| D017023 | Coronary Angiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Lübeck |
| 23538 |
| Germany |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| 0 |
| 44 |
| 0 |
| 44 |
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| D000792 | Angiography |
| D011859 | Radiography |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D006334 | Heart Function Tests |