St Jude Medical has enrolled the first patient in its observational clinical study designed to demonstrate that intravascular imaging technology, when combined with St Jude’s wireless interventional tool, can guide stent implantation in patients with coronary artery disease.
The imaging technology, Optical Coherence Tomography (OCT), captures images that allow physicians to visualise and measure important vessel characteristics for stent planning.
The prospective trial, named ILUMIEN I, will enrol 500 patients who will first undergo a catheterisation procedure that includes using St Jude’s PressureWire Aeris, which 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 determine if there is a need for additional intervention, according to the company.
Belgium Cardiovascular Centre 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).
The data collected throughout the trial will be used in determining stent guidance parametres to achieve PCI optimisation in both stable and unstable coronary disease patients.
St Jude Medical cardiovascular and ablation technology division president Frank Callaghan said the company’s FAME family of trials have demonstrated the value of FFR in the treatment of coronary artery disease, and is now working with leaders in the field to develop further evidence of OCT use and how it can positively impact physician decision-making.
"We are confident that the ILUMIEN I study will result in establishing more efficient lab procedures for physicians and better treatment plans for patients," Callaghan said.