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

NCT ID: NCT01976299

Last Updated: 2017-02-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

578 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Contrast Induced Nephropathy (CIN)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active Treatment

Standard of Care with the AVERT system

Group Type EXPERIMENTAL

AVERT

Intervention Type DEVICE

Standard of Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AVERT

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Osprey Medical, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Roxana Mehran, MD, FACC

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UCSD Medical Center

La Jolla, California, United States

Site Status

Long Beach CA VA Hospital

Long Beach, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status

Stanford Hospital and Clinics

Stanford, California, United States

Site Status

Harbor UCLA Medical Center

Torrance, California, United States

Site Status

The Heart & Vascular Institute of Florida

Clearwater, Florida, United States

Site Status

University of FL College of Medicine - Jacksonville

Jacksonville, Florida, United States

Site Status

St. Vincent's Ambulatory Care (dba St. Vincent's Cardiology)

Jacksonville, Florida, United States

Site Status

Tallahassee Research Institute, Inc.

Tallahassee, Florida, United States

Site Status

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status

St. Joseph's Hospital (Emory)

Atlanta, Georgia, United States

Site Status

Coliseum Medical Center

Macon, Georgia, United States

Site Status

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Jewish Hospital

Louisville, Kentucky, United States

Site Status

Norton Cardiovascular Associates

Louisville, Kentucky, United States

Site Status

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status

Minneapolis Heart Institute Foundation / Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic Hospital, St. Mary's Campus

Rochester, Minnesota, United States

Site Status

North Mississippi Medical Center

Tupelo, Mississippi, United States

Site Status

Saint Luke's Hospital

Kansas City, Missouri, United States

Site Status

Gateway Cardiovascular Research Center, Inc.

St Louis, Missouri, United States

Site Status

Mount Sinai Hospital

New York, New York, United States

Site Status

LeBauer Cardiovascular Research Foundation

Greensboro, North Carolina, United States

Site Status

NC Heart and Vascular Research

Raleigh, North Carolina, United States

Site Status

Oklahoma Heart

Oklahoma City, Oklahoma, United States

Site Status

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

York Hospital

York, Pennsylvania, United States

Site Status

Providence Cardiology LLC

Columbia, South Carolina, United States

Site Status

Baptist Memorial Hospital

Memphis, Tennessee, United States

Site Status

VA North Texas Health Care System

Dallas, Texas, United States

Site Status

CHI St. Luke's Health / Baylor St. Luke's Medical Center

Houston, Texas, United States

Site Status

Houston Methodist Hospital

Houston, Texas, United States

Site Status

The Heart Hospital Baylor Plano

Plano, Texas, United States

Site Status

U of TX Health Science Center San Antonio (UTHSCSA)

San Antonio, Texas, United States

Site Status

Trinity Mother Frances/Cardiovascular Associates of East Texas PA

Tyler, Texas, United States

Site Status

Sentara Cardiovascular Research Institute / Norfolk General

Norfolk, Virginia, United States

Site Status

Heart Center Alfred Hospital

Melbourne, Victoria, Australia

Site Status

Auckland City Hospital

Auckland, , New Zealand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia New Zealand

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30139467 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TP-6364

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Acute KIDnEy Injury in CoviD-19
NCT04583293 COMPLETED
Preventing Acute Kidney Injury
NCT04376619 WITHDRAWN NA
Protect Kidney Trial
NCT04321148 UNKNOWN NA