Abbott Initiates ILUMIEN IV Trial to Assess OCT-Guided Stent Placement in High-Risk, Complex CAD Patients
April 11, 2018—Abbott Vascular announced the initiation of the ILUMIEN IV clinical trial evaluating long-term outcomes of patients undergoing stent implantation guided by optical coherence tomography (OCT) compared to angiography.
According to the company, the prospective, single-blind, multicenter ILUMIEN IV trial will randomize complex and high-risk patients to OCT-guided versus angiography-guided procedures for placement of one or more of Abbott's Xience everolimus-eluting coronary stents.
The primary endpoints are superiority of OCT-guided versus angiography-guided stent implantation in achieving a larger postprocedural lumen dimension and improved clinical cardiovascular outcomes out to 2 years, defined by target vessel failure (a composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization).The ILUMIEN IV trial is the first large-scale randomized global study using Abbott Vascular's OCT imaging in patients with high-risk, complex coronary artery disease, noted the company.
The first patient was enrolled by Franco Fabbiocchi, MD, Director of the Invasive Cardiology Unit IV at IRCCS Centro Cardiologico Monzino in Milan, Italy.
The ILUMIEN IV trial will enroll up to 3,650 patients with high-risk, complex disease at 125 centers in North America, Europe, and Asia to determine if OCT-guided stent procedures result in larger vessel diameters and whether this will improve clinical outcomes for patients compared to stent procedures guided by angiography. The company noted that patients with complex disease may have multiple blockages or totally blocked arteries, as well as other diseases such as diabetes, and these patients account for an increasing number of cases.
Ziad A. Ali, MD, Coprincipal Investigator of the study, commented in Abbott Vascular's announcement, "Today, most of the world uses angiography for stent implantation using a two-dimensional view of the coronary artery to assess a complex three-dimensional structure. Physicians need new technology to help optimize percutaneous coronary intervention, and OCT provides just that, the ability to look at the artery from the outside-in and the inside-out."
Dr. Ali, who is Director of Intravascular Imaging and Physiology at Columbia University Medical Center's Center for Interventional Vascular Therapy in New York, New York, continued, "I'm confident this technology will have a positive impact on clinical practice around the world and we hope to provide evidence for leading medical organizations to update clinical guidelines for stent implantation based on the results of this study."