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

AVERT™ Clinical Trial

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).

Study Overview

• Status: Completed
• Conditions: Contrast Induced Nephropathy (CIN)
• Intervention / Treatment: Device: AVERT

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 578
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Heart Center Alfred Hospital
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital
• United States
  • California
    • La Jolla, California, United States, 92037
      • UCSD Medical Center
    • Long Beach, California, United States, 90812
      • Long Beach CA VA Hospital
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles Medical Center
    • Stanford, California, United States, 94305-5218
      • Stanford Hospital and Clinics
    • Torrance, California, United States, 90509
      • Harbor UCLA Medical Center
  • Florida
    • Clearwater, Florida, United States, 33756
      • The Heart & Vascular Institute Of Florida
    • Jacksonville, Florida, United States, 32209
      • University of FL College of Medicine - Jacksonville
    • Jacksonville, Florida, United States, 32216
      • St. Vincent's Ambulatory Care (dba St. Vincent's Cardiology)
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Research Institute, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown
    • Atlanta, Georgia, United States, 30342
      • St. Joseph's Hospital (Emory)
    • Macon, Georgia, United States, 31217
      • Coliseum Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Jewish Hospital
    • Louisville, Kentucky, United States, 40205
      • Norton Cardiovascular Associates
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation / Abbott Northwestern Hospital
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic Hospital, St. Mary's Campus
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital
    • St. Louis, Missouri, United States, 63128
      • Gateway Cardiovascular Research Center, Inc.
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • LeBauer Cardiovascular Research Foundation
    • Raleigh, North Carolina, United States, 27610
      • NC Heart and Vascular Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Heart
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
    • York, Pennsylvania, United States, 17405
      • York Hospital
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • Providence Cardiology LLC
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Baptist Memorial Hospital
  • Texas
    • Dallas, Texas, United States, 75216
      • VA North Texas Health Care System
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Houston, Texas, United States, 77030
      • CHI St. Luke's Health / Baylor St. Luke's Medical Center
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor Plano
    • San Antonio, Texas, United States, 78229-3900
      • U of TX Health Science Center San Antonio (UTHSCSA)
    • Tyler, Texas, United States, 75701
      • Trinity Mother Frances/Cardiovascular Associates of East Texas PA
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Cardiovascular Research Institute / Norfolk General

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care
Experimental: Active Treatment; Standard of Care with the AVERT system	Device: AVERT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint 1-	Comparison in contrast media volume required between active treament and standard of care.	30 Days
Secondary Endpoint 2- Comparison of Serious Adverse Events.	Comparing event rates of serious adverse events 30 days following the index procedure.	30 Days
Secondary Endpoint 3- Change in Kidney Function.	Change in kidney function by analyzing eGFR 3 to 5 days post procedure.	3-5 days

Collaborators and Investigators

• Sponsor: Osprey Medical, Inc
• Investigators: Principal Investigator: Roxana Mehran, MD, FACC, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: October 29, 2013
• First Submitted That Met QC Criteria: October 29, 2013
• First Posted (Estimate): November 5, 2013

Study Record Updates

• Last Update Posted (Actual): February 28, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: TP-6364