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

Primary Purpose

Contrast Induced Nephropathy (CIN)

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AVERT
Sponsored by
Osprey Medical, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contrast Induced Nephropathy (CIN)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCSD Medical Center
  • Long Beach CA VA Hospital
  • Kaiser Permanente Los Angeles Medical Center
  • Stanford Hospital and Clinics
  • Harbor UCLA Medical Center
  • The Heart & Vascular Institute of Florida
  • University of FL College of Medicine - Jacksonville
  • St. Vincent's Ambulatory Care (dba St. Vincent's Cardiology)
  • Tallahassee Research Institute, Inc.
  • Emory University Hospital Midtown
  • St. Joseph's Hospital (Emory)
  • Coliseum Medical Center
  • University of Illinois at Chicago
  • University of Chicago Medical Center
  • Jewish Hospital
  • Norton Cardiovascular Associates
  • Ochsner Clinic Foundation
  • Minneapolis Heart Institute Foundation / Abbott Northwestern Hospital
  • Mayo Clinic Hospital, St. Mary's Campus
  • North Mississippi Medical Center
  • Saint Luke's Hospital
  • Gateway Cardiovascular Research Center, Inc.
  • Mount Sinai Hospital
  • LeBauer Cardiovascular Research Foundation
  • NC Heart and Vascular Research
  • Oklahoma Heart
  • Allegheny General Hospital
  • York Hospital
  • Providence Cardiology LLC
  • Baptist Memorial Hospital
  • VA North Texas Health Care System
  • CHI St. Luke's Health / Baylor St. Luke's Medical Center
  • Houston Methodist Hospital
  • The Heart Hospital Baylor Plano
  • U of TX Health Science Center San Antonio (UTHSCSA)
  • Trinity Mother Frances/Cardiovascular Associates of East Texas PA
  • Sentara Cardiovascular Research Institute / Norfolk General
  • Heart Center Alfred Hospital
  • Auckland City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active Treatment

Standard of Care

Arm Description

Standard of Care with the AVERT system

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 29, 2013
Last Updated
January 9, 2017
Sponsor
Osprey Medical, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01976299
Brief Title
AVERT™ Clinical Trial for Contrast Media Volume Reduction and Incidence of CIN
Acronym
AVERT™
Official Title
AVERT™ Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Osprey Medical, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Induced Nephropathy (CIN)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
578 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment
Arm Type
Experimental
Arm Description
Standard of Care with the AVERT system
Arm Title
Standard of Care
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
AVERT
Primary Outcome Measure Information:
Title
Primary Effectiveness Endpoint
Description
Reduction in the incidence of Contrast Induced Nephropathy (CIN) by evaluating Serum Creatinine levels in subjects for up to 5 days.
Time Frame
3-5 days
Title
Primary Safety Endpoint- Number of Participants Experiencing a Device Related Serious Adverse Event
Description
Analyze the incidence of device related serious adverse events within the treatment arm.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Secondary Endpoint 1-
Description
Comparison in contrast media volume required between active treament and standard of care.
Time Frame
30 Days
Title
Secondary Endpoint 2- Comparison of Serious Adverse Events.
Description
Comparing event rates of serious adverse events 30 days following the index procedure.
Time Frame
30 Days
Title
Secondary Endpoint 3- Change in Kidney Function.
Description
Change in kidney function by analyzing eGFR 3 to 5 days post procedure.
Time Frame
3-5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roxana Mehran, MD, FACC
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Long Beach CA VA Hospital
City
Long Beach
State/Province
California
ZIP/Postal Code
90812
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5218
Country
United States
Facility Name
Harbor UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
The Heart & Vascular Institute of Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
University of FL College of Medicine - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
St. Vincent's Ambulatory Care (dba St. Vincent's Cardiology)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Tallahassee Research Institute, Inc.
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
St. Joseph's Hospital (Emory)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Coliseum Medical Center
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Jewish Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Norton Cardiovascular Associates
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Minneapolis Heart Institute Foundation / Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic Hospital, St. Mary's Campus
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
North Mississippi Medical Center
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Gateway Cardiovascular Research Center, Inc.
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
LeBauer Cardiovascular Research Foundation
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
NC Heart and Vascular Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Oklahoma Heart
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17405
Country
United States
Facility Name
Providence Cardiology LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Baptist Memorial Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
VA North Texas Health Care System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
CHI St. Luke's Health / Baylor St. Luke's Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
U of TX Health Science Center San Antonio (UTHSCSA)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
Trinity Mother Frances/Cardiovascular Associates of East Texas PA
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Sentara Cardiovascular Research Institute / Norfolk General
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Heart Center Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
30139467
Citation
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.
Results Reference
derived

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

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