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

American College of Cardiology Expands Patient Navigator Program
News | Cath Lab | March 21, 2018
March 21, 2018 — Hundreds of hospitals across the United States will have access to tools and resources to help impro
Videos | Cath Lab | March 15, 2018
A discussion with Hitinder Gurm, M.D., MBBS, FACC, professor, internal medicine, and associate chief clinical officer
News | Cath Lab | February 27, 2018
The American College of Cardiology (ACC) and the Saudi Arabian Cardiac Interventional Society have partnered to...
News | Cath Lab | February 23, 2018
February 23, 2018 — CorFlow Therapeutics AG announced that the company will present new insights into the coronary mi
Teleflex Launches Next-Generation Sympro Elite and Expro Elite Snares
Technology | Cath Lab | February 07, 2018
Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch...
SCAI Advocacy Committee Highlights Reimbursement Reform Efforts in 2017
News | Cath Lab | January 30, 2018
The Society for Cardiovascular Angiography and Interventions (SCAI) highlighted the efforts of its Advocacy Committee...
IAC Releases Cardiovascular Catheterization Accreditation Program
News | Cath Lab | January 25, 2018
January 25, 2018 – The Intersocietal Accreditation Commission (IAC) announced the release of its Cardiovascular Cathe
Videos | Cath Lab | January 04, 2018
Bernadette Speiser, BSN, MSN, CCRN, RCIS, a cardiac cath/EP nurse at Palo Alto Veterans Hospital, Palo Alto, Calif.,
FDA Initiates Class I Recall of Sterilmed Reprocessed Agilis Steerable Introducer Sheath
News | Cath Lab | January 04, 2018
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer...
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA system. 

Feature | Cath Lab | November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Overlay Init