|An OCT image produced by the Optis Integrated imaging system--Courtesy of St. Jude Medical|
St. Jude Medical ($STJ) announced the launch of its third study to compare the company's optical coherence tomography (OCT) imaging to intravascular ultrasound and angiography alone. The three imaging systems will square off in a randomized clinical trial as guides to stent implantation, which occurs during percutaneous coronary intervention procedures.
St. Jude says OCT, provided by the Optis Integrated imaging system, provides superior resolution and can influence pre- and postintervention decision-making, such as the stent size to be deployed. Other key surrogates associated with with reduced stent failure include an increased minimal stent area and the achievement of optimal stent expansion to restore blood flow through the diseased artery
The first patient in the trial was randomized to receive OCT using the Optis at the Columbia University Medical Center, the company says.
"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," said Dr. Ziad Ali of the Columbia University Medical Center, principal investigator of the Ilumien III study. "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 trial is expected to enroll 420 patients at up to 35 sites in Europe, the U.S. and Japan. They will receive PCI for chest pain caused by poor blood flow to the heart, silent ischemia (which does result in chest pain), and heart attacks that are a result of blocked arteries.
As the primary endpoint, the minimum stent area achieved by the three imaging modalities will be compared. That metric is a predictor of in-stent restenosis, or the renarrowing of the stented artery in the months and years following implantation.
"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 first generation diagnostic tools," said St. Jude Chief Medical Officer Dr. Mark Carlson, in a statement. "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."
Unlike the previous Ilumien studies, the third one is randomized, so its results are less likely to be biased by the sample selection decisions.
St. Jude previously said the observational Ilumien studies of 940 patients found that OCT influenced clinical decision-making on 65% of patients, such as those related to stent length and diameter, and was correlated with a reduction in in-hospital heart attacks when used to change treatment strategy pre- or postprocedurally.
In addition, the research found that using OCT or IVUS resulted in similar clinical decisions about stent expansion, and rates of various undesirable outcome like malapposition, which occurs when the stent doesn't adhere to the vessel wall properly.
- read the release
- here's more about the Ilumien studies from ClinicalTrials.Gov