Acute Kidney Injury
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAVERT PLUS
Sponsors
Anand Prasad
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing clinically indicated coronary or peripheral angiography
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observational study of the accuracy of the AVERT PLUS CM system to quantify contrast volume during a clinically indicated procedure. | 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. | The fluid volume of contrast media used during the angiography procedure will be measured in milliliters. |
Outcome results
None listed