The first patient in the trial was enrolled by Dr. Franco Fabbiocchi at Milan, Italy’s IRCCS Centro Cardiologico, the Abbot Park, Ill.-based company said.
“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. 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,” co-principal investigator Dr. Ziad Al of Columbia University Medical Center said in a prepared statement.
In the Ilumien IV trial, which Abbott claims is the first large-scale study of its kind to explore the use of OCT imaging in patients with high-risk complex coronary artery disease, a total of 3,650 patients will be randomly assigned to either OCT or angiography guided placement of one or more Xience everolimus-eluting coronary stents.
During OCT-guided procedures, physicians use high-resolution images from inside the patients vessels to measure appropriate stent dimensions. The OCT systems also aid in verifying stent expansion and fit, which Abbott says are important factors in reducing stent failure.
The Ilumien IV follows findings from the previous Ilumien trial which reported that OCT-guided procedures resulted in superior stent expansions and greater procedural success compared to angiography.
“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,” Abbott vascular biz medical affiars VP Dr. Charles Simonton said in a press release.
Last month, Abbott said it launched a new trial of its CardioMems HF implantable cardiac monitoring system, exploring the device’s ability to improve survival and quality of life for people with New York Heart Association Class II to Class IV heart failure.