OCT-Guided Stent Implantation, IVUS, and Angiography-Guided PCI Compared

A medical device vendor has announced the launch of a clinical study to compare intravascular assessments and Percutaneous Coronary Intervention (PCI) during stent implantation, using guidance by Optical Coherence Tomography (OCT), Intravascular Ultrasound (IVUS) or only angiography.

The ILUMIEN III multicenter randomized study is intended to improve the standard of care for cardiovascular patients by using OCT technology to enable clinicians to provide anatomical images of disease morphology, and automatically measure vessel characteristics that are difficult to assess using IVUS or angiography. The measurements are needed for stent selection, stent deployment, and placement, and can decrease the risk of repeated revascularization.

The OCT technique was developed by St. Jude Medical (St. Paul, MN, USA). Clinicians will use St. Jude’s Optis Integrated and ILUMIEN Optis PCI optimization systems for the study. The study will include up to 420 patients from Europe, the US, and Japan.

Clinicians use diagnostic imaging during PCI procedures to decide on the size of the required stent, and increase the minimal stent area (MSA). This revascularization procedure ensures that the stent expands enough during PCI to restore blood flow.

Dr. Mark Carlson, chief medical officer at St. Jude Medical, said, “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. 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.”

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