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Purpose: To evaluate the accuracy of the AVERT PLUS to monitor contrast volume used during angiographic procedures. This will be a first in man prospective observational study of the accuracy of this system to quantify contrast volume used during clinically indicated angiography in the cardiac catheterization laboratory.
Research Design:
The AVERT PLUS is an FDA 510K cleared device which consists of 1) a contrast delivery modulator designed to reduce unnecessary contract dye delivery to the patient during angiography (coronary or peripheral) and 2) a concomitant contrast monitoring system to precisely measure contrast volume delivered to the patient. This will be a first in man prospective observational study of the accuracy of this system to quantify contrast volume used during clinically indicated angiography in the cardiac catheterization laboratory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVERT PLUS | The AVERT PLUS will be used on the first 10 patients enrolled in the study. The AVERT PLUS is a contrast monitoring system which is used to precisely measure the volume of contrast delivered to the patient. |
| |
| Non device group | The second group of 10 patients will undergo the scheduled angiography using the standard method of measuring contrast dye delivery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVERT PLUS | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Observational study of the accuracy of the AVERT PLUS CM system to quantify contrast volume during a clinically indicated procedure. | The fluid volume of contrast media used during the angiography procedure will be measured in milliliters. | The total volume of contrast received by the subject will be measured at the conclusion of the angiography procedure, procedure duration from 30 minutes to 4 hours dependent on patient's clinical status; no further measurements thereafter. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with cardiovascular disease who are undergoing clinically indicated coronary or peripheral angiography
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| Name | Affiliation | Role |
|---|---|---|
| Michele Shepard | Osprey Medical, Inc | Study Director |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |