AVERT™ Clinical Trial for Contrast Media Volume Reduction and Incidence of CIN
AVERT™
1 other identifier
interventional
578
3 countries
39
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2013
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2013
CompletedFirst Posted
Study publicly available on registry
November 5, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
January 2, 2017
CompletedFebruary 28, 2017
January 1, 2017
1.6 years
October 29, 2013
November 3, 2016
January 9, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
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
Study Arms (2)
Active Treatment
EXPERIMENTALStandard of Care with the AVERT system
Standard of Care
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- The subject is a candidate for a therapeutic percutaneous coronary intervention (PCI) procedure.
- The subject has documented chronic kidney disease (CKD)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
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
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
Related Publications (1)
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.
PMID: 30139467DERIVED
Results Point of Contact
- Title
- Michele Shepard, Vice President of Clinical Affairs
- Organization
- Osprey Medical, Inc
Study Officials
- PRINCIPAL INVESTIGATOR
Roxana Mehran, MD, FACC
Icahn School of Medicine at Mount Sinai
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2013
First Posted
November 5, 2013
Study Start
December 1, 2013
Primary Completion
July 1, 2015
Study Completion
September 1, 2015
Last Updated
February 28, 2017
Results First Posted
January 2, 2017
Record last verified: 2017-01