St. Jude Medical Begins ILUMIEN III Trial of OCT Imaging

June 30, 2015—St. Jude Medical, Inc. announced the commencement of the ILUMIEN III clinical trial. This prospective, international, randomized trial will evaluate the clinical benefits of the company’s optical coherence tomography (OCT) guidance technology during stent implantation.

ILUMIEN III will compare OCT-guided stent implantation to implantation guided by intravascular ultrasound (IVUS) or angiography alone during intravascular assessments and percutaneous coronary intervention (PCI). By assessing each diagnostic system head-to-head, the study should offer clear insight into the ability of OCT to influence clinical outcomes, stated the company.

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.

Ziad A. Ali, MD, who serves as Principal Investigator of the ILUMIEN III study, commented in the company’s press release, “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. 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.” Dr. Ali is Associate Director of Translational Medicine at the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York, New York.

The first patient in the ILUMIEN III trial was enrolled at Columbia University Medical Center. The patient was randomized to PCI guided by the Optis integrated PCI optimization system.

According to St. Jude Medical, the ILUMIEN III trial aims to enroll up to 420 patients at up to 35 sites in Europe, the United States, and Japan. All patients will undergo PCI for stable or unstable angina, silent ischemia, or if they have experienced ST-segment elevation myocardial infarction (STEMI) or non-STEMI events caused by arterial blockages. Patients will be randomized to undergo PCI with OCT, angiography, or IVUS. The primary endpoint will be the degree of minimum stent area achieved.

Previous research, including findings from the ILUMIEN I and II 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, stated the company.