18:03 uur 30-06-2015

St. Jude Medical vergelijkt OCT, echografie en angiografie bij implementatie stent

St. Jude Medical, Inc., een internationaal bedrijf in medische apparatuur, heeft vandaag het begin van het klinische onderzoek ILUMIEN III aangekondigd. Wetenschappers onderzoeken in deze prospectieve, internationale, gerandomiseerde proef wat de voordelen zijn van optische coherentietomografie (OCT) bij het inbrengen van een stent. ILUMIEN III vergelijkt stentimplementaties onder geleide van OCT met implementaties op basis van intravasculaire echografie of angiografie. De laatste twee diagnostische hulpmiddelen hebben bij intravasculaire onderzoeken en dotterbehandelingen een lagere resolutie dan OCT.

ILUMIEN III is tot op heden het grootste gerandomiseerde, op meerdere plekken uitgevoerde onderzoek dat de resultaten van dotterbehandeling met behulp van de drie weergavetechnologieën vergelijkt. Het onderzoek moet duidelijk inzicht geven in de invloed van OCT op klinische resultaten.

St. Jude Medical Announces Launch of the First International Trial to Compare OCT-Guided Stent Implantation to IVUS or Angiography-Guided PCI


Jude Medical, Inc. (NYSE:STJ), 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 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 Dr. Ziad A. Ali,
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 ILUMIEN III trial aims to enroll up to 420 patients at up to 35
sites across Europe, the U.S. and Japan. All patients will undergo PCI
for stable or unstable angina (chest pain caused by insufficient blood
flow to the heart), silent ischemia (restricted blood flow to the heart
that causes no chest pain), or patients who’ve suffered NSTEMI 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.

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

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

About St. Jude Medical

St. Jude Medical is a global medical device manufacturer dedicated to
transforming the treatment of some of the world’s most expensive
epidemic diseases. The company does this by developing cost-effective
medical technologies that save and improve lives of patients around the
world. Headquartered in St. Paul, Minn., St. Jude Medical has four major
clinical focus areas that include cardiac rhythm management, atrial
fibrillation, cardiovascular and neuromodulation. For more information,
please visit sjm.com
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