Evaluation of a Novel Method of Contrast Volume Quantification - AVERT PLUS 2.0

Completed

• Conditions: Acute Kidney Injury
• Interventions: Device: AVERT PLUS

• 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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-10
• Study First Submitted QC: 2015-10-14
• Study First Posted: 2015-10-16
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-19
• Last Update Posted: 2016-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients undergoing clinically indicated coronary or peripheral angiography

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AVERT PLUS	AVERT PLUS	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.

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.