St. Jude Medical Announces Launch of the First International Trial to Compare OCT-Guided Stent Implantation to IVUS or Angiography-Guided PCI
Building on ILUMIEN I and ILUMIEN II, ILUMIEN
III will compare St. Jude Medical’s OCT imaging to intravascular ultrasound and
angiography to further shape the standard of care for cardiovascular patients
ST. PAUL, Minn. St. Jude Medical, Inc. a global medical device company, today announced the launch of 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. By assessing each diagnostic system head-to-head, the study should offer clear insight into OCT’s ability to influence clinical outcomes.
The first patient enrolled within the ILUMIEN III trial was randomized
at
“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.
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 (MSA) and securing appropriate stent expansion during PCI to restore blood flow, a process commonly known as revascularization.
Previous research, including findings from the ILUMIEN I and ILUMIEN 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. The ILUMIEN III study is the next step in assessing the benefits of OCT guidance in relation to first generation imaging tools.
The ILUMIEN III trial aims to enroll up to 420 patients at up
to 35 sites across
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 Dr.
About Optical Coherence Tomography Imaging
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. This can potentially minimize the need for repeat revascularization.
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