US Pivotal Trial of PLC's RenalGuard Begins Enrollment

January 23, 2012—PLC Medical Systems, Inc. (Milford, MA) announced the start of enrollment in the CIN-RG trial, the company's pivotal trial in the United States to study the efficacy of its RenalGuard Therapy and RenalGuard System in the prevention of contrast-induced nephropathy (CIN).

According to PLC, CIN-RG is designed as an adaptive, randomized controlled trial at up to 30 sites in the United States. Enrollment in the trial will include at least 326 patients and potentially up to 652 patients, depending on the outcome of a sample size re-estimation after 163 patients, which will ensure that the trial is sufficiently powered so that the final results are statistically meaningful. The United States study builds on two clinical trials by independent clinical investigators in Europe, both of which showed significant reductions in incident rates of CIN in at-risk patients through the use of RenalGuard compared to the current standard of care, stated the company.

The study's Principal Investigators are Charles Davidson, MD; Richard J. Solomon, MD; and Roxana Mehran, MD. Michael Kim, MD, enrolled the trial's first patient at Mount Sinai Hospital in New York City.

Dr. Mehran, who is Director of Interventional Cardiovascular Research at Mount Sinai, commented, “I am very excited to have this trial underway and overjoyed that Mount Sinai could enroll the first patient. CIN remains a real problem for patients undergoing cardiac catheterizations. RenalGuard trials give us the opportunity to examine a tool that could significantly reduce the incidence of CIN in our at-risk patients.”

Dr. Kim added, “RenalGuard offers us the potential for a method to reduce the incidence of CIN while allowing me as an interventional cardiologist to focus on the catheterization without having to worry that the contrast may be damaging the patient's kidney.”