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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02578173
• Other study ID #: HSC20150682H
• Status: Completed
• Phase: N/A
• First received: October 10, 2015
• Last updated: June 19, 2016
• Start date: October 2015
• Est. completion date: March 2016

Study information

• Verified date: June 2016
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing clinically indicated coronary or peripheral angiography

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Device:
• AVERT PLUS

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Anand Prasad

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No