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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
578
Primary Effectiveness Endpoint
Reduction in the incidence of Contrast Induced Nephropathy (CIN) by evaluating Serum Creatinine levels in subjects for up to 5 days.
Time frame: 3-5 days
Primary Safety Endpoint- Number of Participants Experiencing a Device Related Serious Adverse Event
Analyze the incidence of device related serious adverse events within the treatment arm.
Time frame: 30 days
Secondary Endpoint 1-
Comparison in contrast media volume required between active treament and standard of care.
Time frame: 30 Days
Secondary Endpoint 2- Comparison of Serious Adverse Events.
Comparing event rates of serious adverse events 30 days following the index procedure.
Time frame: 30 Days
Secondary Endpoint 3- Change in Kidney Function.
Change in kidney function by analyzing eGFR 3 to 5 days post procedure.
Time frame: 3-5 days
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