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

Not Applicable

Completed

Conditions: Contrast Induced Nephropathy (CIN)

Interventions: Device: AVERT

Registration Number: NCT01976299

Lead Sponsor: Osprey Medical, Inc

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 578

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Treatment	AVERT	Standard of Care with the AVERT system

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint	3-5 days	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	30 days	Analyze the incidence of device related serious adverse events within the treatment arm.

Secondary Outcome Measures

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

Trial Locations

Locations (39): Emory University Hospital Midtown
🇺🇸
Atlanta, Georgia, United States
UCSD Medical Center
🇺🇸
La Jolla, California, United States
Norton Cardiovascular Associates
🇺🇸
Louisville, Kentucky, United States
Stanford Hospital and Clinics
🇺🇸
Stanford, California, United States
St. Vincent's Ambulatory Care (dba St. Vincent's Cardiology)
🇺🇸
Jacksonville, Florida, United States
Long Beach CA VA Hospital
🇺🇸
Long Beach, California, United States
Harbor UCLA Medical Center
🇺🇸
Torrance, California, United States
NC Heart and Vascular Research
🇺🇸
Raleigh, North Carolina, United States
Jewish Hospital
🇺🇸
Louisville, Kentucky, United States
Sentara Cardiovascular Research Institute / Norfolk General
🇺🇸
Norfolk, Virginia, United States
Coliseum Medical Center
🇺🇸
Macon, Georgia, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸
Los Angeles, California, United States
The Heart & Vascular Institute of Florida
🇺🇸
Clearwater, Florida, United States
University of FL College of Medicine - Jacksonville
🇺🇸
Jacksonville, Florida, United States
St. Joseph's Hospital (Emory)
🇺🇸
Atlanta, Georgia, United States
Mount Sinai Hospital
🇺🇸
New York, New York, United States
LeBauer Cardiovascular Research Foundation
🇺🇸
Greensboro, North Carolina, United States
York Hospital
🇺🇸
York, Pennsylvania, United States
Allegheny General Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
The Heart Hospital Baylor Plano
🇺🇸
Plano, Texas, United States
Trinity Mother Frances/Cardiovascular Associates of East Texas PA
🇺🇸
Tyler, Texas, United States
CHI St. Luke's Health / Baylor St. Luke's Medical Center
🇺🇸
Houston, Texas, United States
Houston Methodist Hospital
🇺🇸
Houston, Texas, United States
University of Illinois at Chicago
🇺🇸
Chicago, Illinois, United States
University of Chicago Medical Center
🇺🇸
Chicago, Illinois, United States
Ochsner Clinic Foundation
🇺🇸
New Orleans, Louisiana, United States
Gateway Cardiovascular Research Center, Inc.
🇺🇸
St. Louis, Missouri, United States
Minneapolis Heart Institute Foundation / Abbott Northwestern Hospital
🇺🇸
Minneapolis, Minnesota, United States
Mayo Clinic Hospital, St. Mary's Campus
🇺🇸
Rochester, Minnesota, United States
U of TX Health Science Center San Antonio (UTHSCSA)
🇺🇸
San Antonio, Texas, United States
Oklahoma Heart
🇺🇸
Oklahoma City, Oklahoma, United States
Heart Center Alfred Hospital
🇦🇺
Melbourne, Victoria, Australia
North Mississippi Medical Center
🇺🇸
Tupelo, Mississippi, United States
Tallahassee Research Institute, Inc.
🇺🇸
Tallahassee, Florida, United States
VA North Texas Health Care System
🇺🇸
Dallas, Texas, United States
Saint Luke's Hospital
🇺🇸
Kansas City, Missouri, United States
Baptist Memorial Hospital
🇺🇸
Memphis, Tennessee, United States
Providence Cardiology LLC
🇺🇸
Columbia, South Carolina, United States
Auckland City Hospital
🇳🇿
Auckland, New Zealand