An observational study in Acute Kidney Injury, sponsored by Anand Prasad. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-21.
Sponsored by Anand Prasad · Observational
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.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's enrollment of 20 is below the median of 150 across 773 observational studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Anand Prasad is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with cardiovascular disease who are undergoing clinically indicated coronary or peripheral angiography
Exclusion Criteria:
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.
Device: AVERT PLUS
The second group of 10 patients will undergo the scheduled angiography using the standard method of measuring contrast dye delivery.
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.
Time frame: 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.
No study locations are listed for this record.
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Anand Prasad