Skip to main content
OpenTrials
Completed

NCT Number: NCT01976299

AVERT™ Clinical Trial for Contrast Media Volume Reduction and Incidence of CIN

The Osprey Medical AVERT System is indicated to reduce contrast media (CM) exposure to the kidneys during percutaneous coronary procedures thereby reducing the risk of contrast induced nephropathy (CIN).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Contrast Induced Nephropathy (CIN)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Center Alfred Hospital, Melbourne, Victoria, Australia

Loading trial locations.

About this study

The purpose of this trial is to assess the AVERT System device, which is designed to limit the volume of CM (Contrast Media) utilized, during a staged therapeutic coronary PCI (Percutaneous Coronary Intervention) or a coronary diagnostic procedure that is anticipated to become a PCI (i.e. ad hoc PCI) for the reduction of CIN (Contrast Induced Nephropathy).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject is a candidate for a therapeutic percutaneous coronary intervention (PCI) procedure.
  • The subject has documented chronic kidney disease (CKD)

Exclusion criteria

  • Subject is in acute renal failure
  • Assessment of ventricular function that cannot be accomplished without the use of the CM.
  • Subject has acute STEMI within 72 hours prior to planned PCI procedure, or is currently having an acute STEMI.
  • Subject is unable to undergo peri-procedural hydration.

Treatment and study plan

AVERT

Device

Primary outcomes

  1. Primary Effectiveness Endpoint

    Time frame: 3-5 days

    Reduction in the incidence of Contrast Induced Nephropathy (CIN) by evaluating Serum Creatinine levels in subjects for up to 5 days.

  2. Primary Safety Endpoint- Number of Participants Experiencing a Device Related Serious Adverse Event

    Time frame: 30 days

    Analyze the incidence of device related serious adverse events within the treatment arm.

Secondary outcomes

  1. Secondary Endpoint 1-

    Time frame: 30 Days

    Comparison in contrast media volume required between active treament and standard of care.

  2. Secondary Endpoint 2- Comparison of Serious Adverse Events.

    Time frame: 30 Days

    Comparing event rates of serious adverse events 30 days following the index procedure.

  3. Secondary Endpoint 3- Change in Kidney Function.

    Time frame: 3-5 days

    Change in kidney function by analyzing eGFR 3 to 5 days post procedure.

Sponsors and collaborators

Lead sponsor

Osprey Medical, Inc

Industry

Registry information

Official study title

AVERT™ Clinical Trial

Acronym: AVERT™

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 5, 2013
Registry last updated
Feb 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.