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

Not Applicable

Completed

• Conditions: Contrast Induced Nephropathy (CIN)

• 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).

Study Timeline

• Study First Submitted: 2013-10-29
• Study First Submitted QC: 2013-10-29
• Study First Posted: 2013-11-05
• Study Start: 2013-12
• Primary Completion: 2015-07
• Study Completion: 2015-09
• Results First Submitted: 2016-11-03
• Results First Submitted QC: 2016-11-03
• Status Verified: 2017-01
• Results First Posted: 2017-01-02
• Last Update Submitted: 2017-01-09
• Last Update Posted: 2017-02-28

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

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)

UCSD Medical Center; 🇺🇸 La Jolla, California, United States

Long Beach CA VA Hospital; 🇺🇸 Long Beach, California, United States

Kaiser Permanente Los Angeles Medical Center; 🇺🇸 Los Angeles, California, United States

Stanford Hospital and Clinics; 🇺🇸 Stanford, California, United States

Harbor UCLA Medical Center; 🇺🇸 Torrance, 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. Vincent's Ambulatory Care (dba St. Vincent's Cardiology); 🇺🇸 Jacksonville, Florida, United States

Tallahassee Research Institute, Inc.; 🇺🇸 Tallahassee, Florida, United States

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States

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