Clinical trial NCT01976299: AVERT™ Clinical Trial for Contrast Media Volume Reduction and Incidence of CIN
Official title: AVERT™ Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contrast Induced Nephropathy (CIN)
Lead sponsor: Osprey Medical, Inc
Sponsor class: INDUSTRY
First posted: 2013-11-05
Enrollment: 578
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: 3-5 days
measure: Primary Safety Endpoint- Number of Participants Experiencing a Device Related Serious Adverse Event
timeFrame: 30 days
Secondary outcomes:
measure: Secondary Endpoint 1-
timeFrame: 30 Days
measure: Secondary Endpoint 2- Comparison of Serious Adverse Events.
timeFrame: 30 Days
measure: Secondary Endpoint 3- Change in Kidney Function.
timeFrame: 3-5 days
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Medical Center
state: California
city: Long Beach
country: United States
facility: Long Beach CA VA Hospital
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Torrance
country: United States
facility: Harbor UCLA Medical Center
state: California
city: Clearwater
country: United States
facility: The Heart & Vascular Institute of Florida
state: Florida
city: Jacksonville
country: United States
facility: University of FL College of Medicine - Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: St. Vincent's Ambulatory Care (dba St. Vincent's Cardiology)
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute, Inc.
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: St. Joseph's Hospital (Emory)
state: Georgia
city: Macon
country: United States
facility: Coliseum Medical Center
state: Georgia
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Cardiovascular Associates
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation / Abbott Northwestern Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Hospital, St. Mary's Campus
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
city: St. Louis
country: United States
facility: Gateway Cardiovascular Research Center, Inc.
state: Missouri
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Greensboro
country: United States
facility: LeBauer Cardiovascular Research Foundation
state: North Carolina
city: Raleigh
country: United States
facility: NC Heart and Vascular Research
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma Heart
state: Oklahoma
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Columbia
country: United States
facility: Providence Cardiology LLC
state: South Carolina
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Dallas
country: United States
facility: VA North Texas Health Care System
state: Texas
city: Houston
country: United States
facility: CHI St. Luke's Health / Baylor St. Luke's Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: San Antonio
country: United States
facility: U of TX Health Science Center San Antonio (UTHSCSA)
state: Texas
city: Tyler
country: United States
facility: Trinity Mother Frances/Cardiovascular Associates of East Texas PA
state: Texas
city: Norfolk
country: United States
facility: Sentara Cardiovascular Research Institute / Norfolk General
state: Virginia
city: Melbourne
country: Australia
facility: Heart Center Alfred Hospital
state: Victoria
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Roxana Mehran, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References:
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.