St. Jude Medical Launches Trial to Compare Image-Guided Stent Implantation Technologies

St. Jude Medical Inc. has begun the Ilumien III clinical trial, a prospective, international, randomized trial evaluating the clinical benefits of the company’s optical coherence tomography (OCT) guidance during stent implantation. The Ilumien III study will compare OCT-guided stent implantation to implantation guided by intravascular ultrasound (IVUS) or angiography alone, diagnostic tools that offer less resolution than OCT during intravascular assessments and percutaneous coronary intervention (PCI).

The Ilumien III study is the largest multicenter randomized study to date to compare PCI outcomes associated with all three imaging tools, according to St. Jude Medical officials. By assessing each diagnostic system head-to-head, the study should offer clear insight into OCT’s ability to influence clinical outcomes, officials noted.

The first patient enrolled within the Ilumien III trial was randomized at Columbia University Medical Center in New York, N.Y., and underwent PCI guided by the St. Jude Medical Optis Integrated PCI optimization system.

“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 Ziad A. Ali, M.D., associate director of translational medicine at the Columbia University Medical Center’s Center for Interventional Vascular Therapy and principal investigator of the 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.”

During PCI procedures, physicians use diagnostic imaging to make decisions related to stent sizing and to assess how to best keep the artery expanded to restore blood flow to the heart. One key factor in reducing stent failure is increasing the minimal stent area and securing appropriate stent expansion during PCI to restore blood flow, a process commonly known as revascularization.

Previous research, including findings from the first two Ilumien studies, has shown that with superior resolution over IVUS and angiography, St. Jude Medical’s OCT imaging technology can influence pre- and post-PCI decision making, stent sizing and deployment. The Ilumien III study is the next step in assessing the benefits of OCT guidance in relation to first generation imaging tools.

The trial aims to enroll up to 420 patients at up to 35 sites across Europe, the United States and Japan. All patients will undergo PCI for stable or unstable angina (chest pain caused by insufficient blood flow to the heart), silent ischemia (restricted blood flow to the heart that causes no chest pain), or patients who’ve suffered heart attacks due to arterial blockages. Patients will be randomized to undergo PCI with either OCT, angiography or IVUS and the primary endpoint will be the degree of minimum stent area achieved.

Physicians assessing patients in the Ilumien III study will employ the St. Jude Medical Optis Integrated and Ilumien Optis PCI optimization systems to assess patients randomized to OCT-guided stent 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 Mark Carlson, M.D., chief medical officer at St. Jude Medical. “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.”

St. Jude Medical’s OCT technology is an intravascular imaging tool that uses light to provide anatomical images of disease morphology and automated measurements. With OCT technology, physicians can visualize and measure important vessel characteristics that are otherwise not visible or difficult to assess with the older imaging technology. As a result, OCT can provide automated, highly accurate measurements that can help guide stent selection and deployment and assess stent placement to help ensure successful procedures, according to the company. This can potentially minimize the need for repeat revascularization.

Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation.