Feature | Intravascular Imaging | July 10, 2015

St. Jude Medical Launches ILUMIEN III Trial

Study will compare St. Jude™s OCT technology to intravascular ultrasound and angiography for stent implantation guidance

St. Jude Medical, OCT, ILUMIEN III, IVUS, angiography, PCI

July 9, 2015 - St. Jude Medical, Inc. announced the launch of the ILUMIEN III clinical trial on June 30. ILUMIEN III is a prospective, international, randomized trial evaluating the clinical benefits of the company's optical coherence tomography (OCT) guidance during stent implantation. The 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 Columbia University Medical Center 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 ILUMIEN III 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 (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 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, silent ischemia, or patients who've suffered NSTEMI (non-ST segment myocardial infarction) or STEMI 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.

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.

For more information: www.sjm.com

Related Content

Sponsored Content | Videos | Cath Lab | October 24, 2018
Michael Flaherty, M.D., discusses a study published in Circulation Research which finds that use of hemodynamic suppo
Philips Showcases Integrated Solutions for Cardiovascular Care at TCT 2018
News | Cath Lab | September 20, 2018
At the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, Sept. 21–25 in San Diego, Philips is showcasing...
Sponsored Content | Videos | Cath Lab | September 19, 2018
William O’Neill, M.D., outlines his recent clinical publication of AMICS patients from the Impella Quality (IQ) datab
A complex PCI case to revascularize a chronic total occlusion (CTO) at Henry Ford Hospital in Detroit. Complex PCI and CHIP cases are increasing patient volumes in the cath lab and using a minimally invasive approach in patients who otherwise would have been sent for CABG. Pictured is Khaldoon Alaswad, M.D. DAIC staff photo by Dave Fornell

A complex PCI case to revascularize a chronic total occlusion (CTO) at Henry Ford Hospital in Detroit. Complex PCI and CHIP cases are increasing patient volumes in the cath lab and using a minimally invasive approach in patients who otherwise would have been sent for CABG. Pictured is Khaldoon Alaswad, M.D. (right) who is proctoring a fellow in treating CTOs.

Feature | Cath Lab | September 13, 2018 | Artur Kim, Kamran Zamanian
Coronary artery disease (CAD) is a multifaceted disease that demands various approaches in terms of diagnosis and tre
Videos | Cath Lab | August 13, 2018
Jeffrey Schussler, M.D., FACC, FSCAI, FSCCT, FACP, interventional cardiologist at Baylor Scott White Heart and Vascul
Shockwave Launches Coronary Intravascular Lithotripsy in Europe
News | Cath Lab | May 30, 2018
Shockwave Medical recently announced the European commercial availability of Intravascular Lithotripsy (IVL) for...
FFR software on the GE Centricity CVIS. A trial from the 2018 EuroPCR meeting showed FFR improves long-term outcomes.
News | Cath Lab | May 29, 2018
May 29, 2018 — Ongoing controversy exists regarding the role of percutaneous coronary intervention (PCI) for stable c
Overlay Init