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

Anand Prasad

Status: Completed

Conditions: Acute Kidney Injury

Treatments: Device: AVERT PLUS

Study type: Observational

Funder types: Other

Identifiers

NCT02578173

HSC20150682H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing clinically indicated coronary or peripheral angiography

Exclusion criteria

• None

Trial design

20 participants in 2 patient groups

AVERT PLUS

Description:

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.

Treatment:

Device: AVERT PLUS

Non device group

Description:

The second group of 10 patients will undergo the scheduled angiography using the standard method of measuring contrast dye delivery.