St. Paul, Minn.-based St. Jude said the 420-patient Ilumien III trial will compare treatment with its Optis Integrated and Ilumien Optis percutaneous coronary intervention optimization systems in treating patients with stable or unstable angina, silent ischemia or NSTEMI or STEMI heart attacks. Subjects will be randomized to undergo PCI with either OCT, angiography or IVUS, with a primary endpoint of the degree of minimum stent area achieved. The 1st patient, treated at the Columbia University Medical Center in New York, was randomized to the OCT arm of the study, the company said.
“We are excited about Ilumien III because this is the first randomized study of its kind to directly compare patient outcomes associated with guidance by OCT, IVUS or angiography during PCI,” principal investigator Dr. Ziad Ali said in prepared remarks. “Ilumien III is unique because we will be specifically assessing the utility of OCT in imaging guided PCI and gaining valuable insight into how OCT imaging can help shape patient care.”
“The launch of Ilumien III is an important step in assessing St. Jude Medical’s OCT technology and its ability to improve stent implantation over 1st-generation diagnostic tools,” added St. Jude’s chief medical officer Dr. Mark Carlson. “The study builds on important research showing the benefits of OCT imaging in supporting clinical decision making, and we’re excited to have this important trial underway.”