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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02434055
Acronym
AVERT-PLUS
Enrollment
10
Registered
2015-05-05
Start date
2015-04-30
Completion date
2015-06-30
Last updated
2015-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extravasation of Contrast Media

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.

Interventions

Sponsors

Osprey Medical, Inc
CollaboratorINDUSTRY
Anand Prasad
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Observational study of the accuracy of this system to quantify contrast volume during a clinical indicated procedureDuring procedure

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026