News | December 26, 2012

St. Jude Medical Enrolls First Patient in ILUMIEN I Study

Study aims to further understand how FFR, OCT influence physician decision-making for coronary intervention

December 26, 2012 — St. Jude Medical Inc. announced the first patient enrollment in its ILUMIEN I clinical study. The observational study is designed to show the optimal way optical coherence tomography (OCT), combined with the PressureWire Aeris, a wireless interventional tool that measures fractional flow reserve (FFR), can guide stent implantation in patients with coronary artery disease.

The study will observe and record how physicians treat patients undergoing percutaneous coronary intervention (PCI), and will also measure outcomes according to various procedural parameters. Commonly known as coronary angioplasty, PCI is a nonsurgical procedure used to treat narrowed coronary arteries of the heart found in coronary artery disease. Gathering this information will assist in establishing guidance parameters for optimal stenting, which may result in improved clinical outcomes for patients undergoing PCI.

“Improving patients’ quality of life is our highest priority as physicians, and if we can successfully treat our patients while streamlining workflow, the benefit is even greater,” said David Holmes, ILUMIEN I global steering committee member and U.S. coordinating investigator from Mayo Clinic in Rochester, Minn. “The ILUMIEN I study is an important step towards guiding physician decisions during PCI, ultimately leading to better clinical outcomes.”

OCT images allow physicians to visualize and measure important vessel characteristics for stent planning. Following stent placement, the high resolution images offered by OCT show precisely how the stent is holding the artery open and whether it is positioned correctly against the artery wall, informing treatment and follow-up strategies. When combined with the PressureWire Aeris to measure FFR, the use of OCT potentially minimizes the need for urgent hospital visits, repeat revascularizations or other complications.

"OCT offers a remarkably clear image from inside the coronary vessel, which is something we haven't been able to see previously," said William Wijns, ILUMIEN I global steering committee member and international coordinating investigator from the Cardiovascular Center, Aalst, Belgium. "Using this technology, I can assess important vessel characteristics before placing the stent, confirm success after placing the stent, and identify potential problem areas to quickly understand how to best treat my patient."

The ILUMIEN I prospective, observational study will enroll approximately 500 patients at 40 medical centers around the world. Patients will first undergo a catheterization procedure, which includes using the PressureWire Aeris to take FFR measurements and establish the severity of blood flow restriction, to determine the level of treatment needed. In arteries where FFR has determined that treatment is needed, OCT images will then be collected to help inform stent selection and placement. Following stent placement, OCT images will be collected again to help inform the physician regarding the need for additional intervention. Data will be collected before and after stenting, as well as throughout the 12-month follow-up period, to understand the impact of coronary lesion characteristics and stent deployment on patient outcomes. All collected data will be compiled and used in determining stent guidance parameters to achieve PCI optimization in both stable and unstable coronary disease patients.

“Our FAME family of trials have demonstrated the compelling value of FFR in the treatment of coronary artery disease, and we are now working with leaders in the field to develop further evidence of OCT use and how it can positively impact physician decision-making,” said Frank J. Callaghan, president of the Cardiovascular and Ablation Technology Division at St. Jude Medical. “We are confident that the ILUMIEN I study will result in establishing more efficient lab procedures for physicians and better treatment plans for patients.”

For more information: www.sjm.com

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