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

Osprey Medical

Status

Completed

Conditions

Contrast Induced Nephropathy (CIN)

Treatments

Device: AVERT

Study type

Interventional

Funder types

Industry

Identifiers

NCT01976299

TP-6364

Details and patient eligibility

About

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).

Full 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).

Enrollment

578 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.