A Study to Evaluate RenalGuard® System Safety & Efficacy When Compared With Standard Care in the Prevention of Contrast Induced NephRopathy in the SettinG of a Catheterization Laboratory
Contrast-Induced Nephropathy (CIN) can occur when patients with pre-existing kidney problems undergo procedures that use iodinated contrast media, such as cardiac catheterizations. RenalGuard Therapy was developed to enable the patient to clear the contrast out of their kidney before it can do significant damage. This study aims to enroll patients with increased risk of developing CIN who are scheduled for a cardiovascular catheterization. Patients will be randomized to either RenalGuard therapy or standard therapy.
• Male or non-pregnant female equal or greater than the age of 18 years old and is able to provide informed consent.
• Subject is scheduled to undergo an elective catheterization procedure
• Hemodynamically stable
• At increased risk of developing CIN
• Subject has agreed to all follow-up testing.