St. Jude Medical enrolls first patient in OCT system clinical study
Medical device maker St. Jude Medical (St. Paul, MN) has enrolled the first patient in its first clinical study for its ILUMIEN multimodal system that pairs optical coherence tomography (OCT) and fractional flow reserve (FFR) technologies.
The ILUMIEN I observational study will show how OCT, combined with the company's PressureWire Aeris wireless interventional tool that measures FFR, can guide stent implantation in patients with coronary artery disease. The study will observe and record how physicians treat patients while undergoing percutaneous coronary intervention (PCI), and will also measure outcomes according to various procedural parameters. Commonly known as coronary angioplasty, PCI is a non-surgical procedure used to treat narrowed coronary arteries of the heart found in coronary artery disease. Gathering this information will assist in establishing guidance parameters for optimal stenting, which may result in improved clinical outcomes for patients undergoing PCI.
OCT images allow physicians to visualize and measure important vessel characteristics for stent planning. Following stent placement, the high-resolution images offered by OCT--for the first time--show precisely how the stent is holding the artery open and whether it is positioned correctly against the artery wall, informing treatment and follow-up strategies. When combined with the PressureWire Aeris to measure FFR, the use of OCT potentially minimizes the need for urgent hospital visits, repeat revascularizations, or other complications.
The study will enroll approximately 500 patients at 40 medical centers around the world. Patients will first undergo a catheterization procedure, which includes using the PressureWire Aeris to take FFR measurements and establish the severity of blood flow restriction to determine the level of treatment needed. In arteries where FFR has determined that treatment is needed, OCT images will then be collected to help inform stent selection and placement. Following stent placement, OCT images will be collected again to help inform the physician regarding the need for additional intervention. Data will be collected before and after stenting, as well as throughout the twelve month follow-up period, to understand the impact of coronary lesion characteristics and stent deployment on patient outcomes. All collected data will be compiled and used in determining stent guidance parameters to achieve PCI optimization in both stable and unstable coronary disease patients.
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