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

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Device: AVERT PLUS

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 Type: Observational
• Enrollment (Actual): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with cardiovascular disease who are undergoing clinically indicated coronary or peripheral angiography

Description

Inclusion Criteria:

• Patients undergoing clinically indicated coronary or peripheral angiography

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: AVERT PLUS
Non device group; The second group of 10 patients will undergo the scheduled angiography using the standard method of measuring contrast dye delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.

Collaborators and Investigators

• Sponsor: Anand Prasad
• Investigators: Study Director: Michele Shepard, Osprey Medical, Inc

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: October 10, 2015
• First Submitted That Met QC Criteria: October 14, 2015
• First Posted (Estimate): October 16, 2015

Study Record Updates

• Last Update Posted (Estimate): June 21, 2016
• Last Update Submitted That Met QC Criteria: June 19, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: HSC20150682H