Global medical device company St Jude Medical has enrolled the first patient in its ILUMIEN I observational clinical study.
The objective of the study is to determine that an intravascular imaging technology, Optical Coherence Tomography (OCT), when combined with St Jude’s wireless interventional tool, PressureWire Aeris, can guide stent implantation in patients with coronary artery disease.
The OCT captures images which allow physicians to visualize and measure important vessel characteristics for stent planning.
The prospective trial will enroll 500 patients who will first undergo a catheterization procedure with PressureWire Aeris that measures fractional flow reserve (FFR).
OCT images will be collected, after FFR has determined that treatment is needed, 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, claims the company.
Belgium Cardiovascular Center international coordinating investigator and ILUMIEN I global steering committee member professor William Wijns said, "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 trial will also collect twelve month follow-up period data to understand the impact of coronary lesion characteristics and stent deployment in patient undergoing percutaneous coronary intervention (PCI).
St. Jude Medical cardiovascular and ablation technology division president Frank Callaghan said, "We are confident that the ILUMIEN I study will result in establishing more efficient lab procedures for physicians and better treatment plans for patients."