Infraredx has announced the enrollment of 1,000 patients in its Lipid-Rich Plaque (LRP) study. The study is a prospective, multicentre clinical trial designed to identify a correlation between lipid-rich plaques detected by the company’s TVC Imaging System and the occurrence of a cardiac event within two years. The first-in-class 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.
A press release reports that the TVC Imaging System is FDA-approved 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 (PCI) as a means to prevent coronary events.
Current PCI imaging technologies are limited in the information they can provide about non-flow limiting plaques that may be dangerous. The results of TVC imaging are presented in the form of a chemogram, an easy-to-read road map of cholesterol throughout the vessel scanned. Several prior 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.
“With 1,000 patients enrolled at 41 investigator sites across the USA and Europe, we are excited by the rapid progress of the LRP Study,” said Ron Waksman, principal investigator 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.”
“We are most grateful to the many physicians and health professionals that have contributed to the rapid enrolment of patients in this important study,” said James Muller, founder and chief medical officer of Infraredx.