The adaptive, randomized controlled CIN-RG trial, enrolling at least 326 patients and potentially up to 652 patients, is designed to assess the safety and efficacy of the RenalGuard therapy and RenalGuard system in the prevention of contrast-induced nephropathy (CIN).
Mount Sinai Hospital Coronary Care Unit Coronary Care Unit director Michael Kim said RenalGuard offers them the potential for a method to reduce the incidence of CIN while allowing interventional cardiologist to focus on the catheterization without having to worry that the contrast may be damaging the patient’s kidney.
PLC Systems president and CEO Mark Tauscher said using lessons learned from the clinical trials of RenalGuard in Europe as well as other clinical developments since 2008, they made slight modifications to their original trial protocol that they believe will make it more robust.
"This is a very important step on our path forward to seek the US Food and Drug Administration (FDA) approval to market RenalGuard in the US," Tauscher said.
