Abbott has launched a clinical trial (ILUMIEN IV) to investigate long-term outcomes in coronary artery disease patients who are undergoing stent implantation guided by its optical coherence tomography (OCT) technology.
The company’s OCT platforms are designed to help physicians during stent implantation by allowing direct imaging of patient’s vessels to facilitate the accurate measurement of dimensions so they can choose the best-fitting implant.
Abbott says that the imaging technology also enables physicians to ensure proper positioning of the stent against a vessel wall in order to minimise failure.
The single-blind, multi-centre, randomised trial will compare the high-resolution light-based technique with a standard X-ray-guided method, angiography, in about 3,650 subjects having high-risk, complex coronary artery disease.
It will recruit patients who are set to be implanted with XIENCE everolimus-eluting coronary stents at 125 sites across North America, Europe and Asia.
The primary goal of the trial is to establish whether OCT-guided stent procedures will allow enhanced blood flow through larger vessel diameters and result in better clinical outcomes for patients when compared to those guided by angiography.
Abbott vascular business Medical Affairs chief medical officer and divisional vice-president Charles Simonton said: “Abbott is committed to providing doctors and patients with life-changing technology, and there is a growing body of evidence that OCT-guided stent implantation may result in better outcomes for patients.
“We’re excited to initiate this trial to generate the groundbreaking data that would support use of OCT over angiography to achieve better outcomes for patients with high-risk disease.”
Previous studies are reported to have demonstrated superior stent expansion with OCT imaging, which is also said to have aided in the detection of any artery wall damage caused during placement of the stent.