Evaluation of a Novel Method of Contrast Volume Quantification - AVERT PLUS 2.0
- Conditions
- Acute Kidney Injury
- Registration Number
- NCT02578173
- Lead Sponsor
- Anand Prasad
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Patients undergoing clinically indicated coronary or peripheral angiography
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method