NCT01976299|CompletedResults
AVERT™ Clinical Trial for Contrast Media Volume Reduction and Incidence of CIN
AVERT™
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AVERT™
Sponsor study identifier
interventional
578
3 countries
39
Study Start
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2015
Actual (reported)Study Completion
September 2015
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 29, 2013
Actual (reported)November 5, 2013
Actual (reported)December 2013
Date type not reportedThis date has not been verified as actual or estimated.
July 2015
Actual (reported)September 2015
Actual (reported)January 2, 2017
Actual (reported)Primary Effectiveness Endpoint
Reduction in the incidence of Contrast Induced Nephropathy (CIN) by evaluating Serum Creatinine levels in subjects for up to 5 days.
3-5 days
Primary Safety Endpoint- Number of Participants Experiencing a Device Related Serious Adverse Event
Analyze the incidence of device related serious adverse events within the treatment arm.
30 days
Secondary Endpoint 1-
30 Days
Secondary Endpoint 2- Comparison of Serious Adverse Events.
30 Days
Secondary Endpoint 3- Change in Kidney Function.
3-5 days
Standard of Care with the AVERT system
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
UCSD Medical Center
La Jolla, California, 92037, United States
Long Beach CA VA Hospital
Long Beach, California, 90812, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Stanford Hospital and Clinics
Stanford, California, 94305-5218, United States
Harbor UCLA Medical Center
Torrance, California, 90509, United States
The Heart & Vascular Institute of Florida
Clearwater, Florida, 33756, United States
University of FL College of Medicine - Jacksonville
Mehran R, Faggioni M, Chandrasekhar J, Angiolillo DJ, Bertolet B, Jobe RL, Al-Joundi B, Brar S, Dangas G, Batchelor W, Prasad A, Gurm HS, Tumlin J, Stone GW. Effect of a Contrast Modulation System on Contrast Media Use and the Rate of Acute Kidney Injury After Coronary Angiography. JACC Cardiovasc Interv. 2018 Aug 27;11(16):1601-1610. doi: 10.1016/j.jcin.2018.04.007.
Roxana Mehran, MD, FACC
Icahn School of Medicine at Mount Sinai
578 participants (actual enrollment reported by the registry).
First Submitted
October 29, 2013
First Posted
November 5, 2013
Study Start
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Jacksonville, Florida, 32209, United States
St. Vincent's Ambulatory Care (dba St. Vincent's Cardiology)
Jacksonville, Florida, 32216, United States
Tallahassee Research Institute, Inc.
Tallahassee, Florida, 32308, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
St. Joseph's Hospital (Emory)
Atlanta, Georgia, 30342, United States
Coliseum Medical Center
Macon, Georgia, 31217, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Jewish Hospital
Louisville, Kentucky, 40202, United States
Norton Cardiovascular Associates
Louisville, Kentucky, 40205, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Minneapolis Heart Institute Foundation / Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Mayo Clinic Hospital, St. Mary's Campus
Rochester, Minnesota, 55902, United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801, United States
Saint Luke's Hospital
Kansas City, Missouri, 64111, United States
Gateway Cardiovascular Research Center, Inc.
St Louis, Missouri, 63128, United States
Mount Sinai Hospital
New York, New York, 10029, United States
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, 27401, United States
NC Heart and Vascular Research
Raleigh, North Carolina, 27610, United States
Oklahoma Heart
Oklahoma City, Oklahoma, 73120, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
York Hospital
York, Pennsylvania, 17405, United States
Providence Cardiology LLC
Columbia, South Carolina, 29204, United States
Baptist Memorial Hospital
Memphis, Tennessee, 38120, United States
VA North Texas Health Care System
Dallas, Texas, 75216, United States
CHI St. Luke's Health / Baylor St. Luke's Medical Center
Houston, Texas, 77030, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093, United States
U of TX Health Science Center San Antonio (UTHSCSA)
San Antonio, Texas, 78229-3900, United States
Trinity Mother Frances/Cardiovascular Associates of East Texas PA
Tyler, Texas, 75701, United States
Sentara Cardiovascular Research Institute / Norfolk General
Norfolk, Virginia, 23507, United States
Heart Center Alfred Hospital
Melbourne, Victoria, 3004, Australia
Auckland City Hospital
Auckland, 1023, New Zealand
Primary Completion
July 2015
Actual (reported)Study Completion
September 2015
Actual (reported)Last Updated
February 28, 2017
Results First Posted
January 2, 2017
Record last verified: 2017-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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