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

Biotronik Studies Demonstrate Efficacy of Minimizing Metal Burden in SFA Therapy
News | Stents Bare Metal| September 22, 2017
Physicians demonstrated that reducing metal burden in superficial femoral artery (SFA) therapy could effectively reduce...
Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
MyoKardia Presents Additional Positive Data From Phase 2 PIONEER-HCM Study at HFSA 2017
News | Heart Failure| September 21, 2017
MyoKardia Inc. announced that additional positive data from the first patient cohort of its Phase 2 PIONEER-HCM study...
Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Overlay Init