Clinical Trial: Evaluation of a Novel Method of Contrast Volume Quantification - AVERT PLUS
Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational
Official Title: Evaluation of a Novel Method of Contrast Volume Quantification - The AVERT PLUS
Brief Summary:
Purpose: To evaluate the accuracy of the AVERT PLUS to monitor contrast volume used during angiographic procedures.
Research Design: The AVERT PLUS is an FDA 510K cleared device which consists of a contrast delivery modulator designed to reduce unnecessary contrast dye delivery to the patient during angiography (coronary or peripheral) and a concomitant 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 contract volume used during clinically indicated angiography in the cardiac catheterization laboratory.
Detailed Summary: Thirty consecutive subjects who consent to participate and are undergoing planned angiography will be enrolled. The AVERT PLUS is a system which is external to the patient and connected to the control syringe that the physician uses to deliver the contrast dye to the patient. For each injection that the physician performs, the starting syringe volume, the ending syringe volume, and the net contrast delivered to the patient will be recorded. At the same time, the net volume delivered to the patient will also be recorded from the AVERT PLUS console. For each injection, these two sets of variables will be compared to determine accuracy of the AVERT PLUS to quantify net contrast volume used.
Sponsor: Anand Prasad
Current Primary Outcome: Observational study of the accuracy of this system to quantify contrast volume during a clinical indicated procedure [ Time Frame: During procedure ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: The University of Texas Health Science Center at San Antonio
Dates:
Date Received: April 29, 2015
Date Started: April 2015
Date Completion:
Last Updated: June 16, 2015
Last Verified: June 2015
