Lipid-Rich Plaque Study Using Infraredx's TVC Imaging System Reaches Enrollment Milestone

April 27, 2015—Infraredx, Inc. announced the enrollment of 1,000 patients in the Lipid-Rich Plaque (LRP) study, a prospective, multicenter clinical trial designed to identify a correlation between lipid-rich plaques detected by Infraredx’s TVC Imaging System and the occurrence of a cardiac event within 2 years. The study, which started in January 2014, has an estimated enrollment goal of 9,000 patients, with a completion date of December 2018.

The TVC Imaging System is specifically approved in both the United States and Europe for the detection of lipid-core plaques. The multimodality TVC (true vessel characterization) Imaging System was launched in November 2011.

Ron Waksman, MD, who serves as Principal Investigator of the LRP study, commented in the company’s announcement, “With 1,000 patients enrolled at 41 investigator sites across the United States and Europe, we are excited by the rapid progress of the LRP study. Once complete, the LRP study data could redefine the role of intravascular imaging and lay the groundwork for changing standard protocols for managing coronary artery disease.”

According to Infraredx, the TVC dual-modality intravascular imaging system integrates near-infrared spectroscopy (NIRS) with intravascular ultrasound (IVUS) technology, allowing clinicians the ability to assess vessel structure and plaque composition. The device is approved by the US Food and Drug Administration to identify lipid-core plaques that may cause heart attacks. Identification of such plaques would be a major step toward the development of percutaneous coronary intervention as a means to prevent coronary events, noted the company.
 
Infraredx stated that the results of TVC imaging are presented in the form of the company’s Chemogram, an easy-to-read road map of cholesterol throughout the vessel scanned. Several previous studies in patients who have already experienced a coronary event have revealed a prominent signal detected by NIRS at the site of the culprit lesion. These studies led to the initiation of the LRP study to test the hypothesis that a plaque with a large lipid core identified by NIRS imaging is a vulnerable plaque likely to cause a future coronary event. The goal is to prove that vulnerable plaques can be identified by NIRS and provide a target for personalized therapy to prevent coronary events.

In March 2015, Infraredx announced the introduction of the Advanced TVC Imaging System.