Evaluation of a Novel Method of Contrast Volume Quantification - AVERT PLUS

Terminated

• Conditions: Extravasation of Contrast Media

• Registration Number: NCT02434055
• Lead Sponsor: Anand Prasad

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 Description

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-29
• Study First Submitted QC: 2015-04-29
• Study First Posted: 2015-05-05
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-16
• Last Update Posted: 2015-06-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• subjects aged 18 or older with cardiovascular disease scheduled to undergo clinically indicated coronary or peripheral angiography who give informed consent to participate.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Observational study of the accuracy of this system to quantify contrast volume during a clinical indicated procedure	During procedure