Clinical trial will test 3D imaging technique for stent placement
A clinical trial is being started to determine whether a light-based, three-dimensional imaging technique is more effective than X-ray-based angiography to treat patients with complex coronary artery disease who receive stents to keep arteries open.
Abbott is leading the study to determine whether advanced imaging improves the outcomes of patients by resulting in stent placements that produce larger vessel diameters. Improved blood flow to the heart is essential in reducing the likelihood of heart disease or further occlusion of vessels serving the cardiac muscles.
Abbott says the study will be the first large-scale randomized global study using the company’s technology, called optical coherence tomography (OCT), to treat patients with high-risk complex forms of the artery disease.
Patients in the study will be randomly assigned to groups using OCT or traditional angiography (employing X-ray imaging). Both imaging modalities will be used to guide placement of one or more drug-eluting coronary stents.
During stent implantation guided by one of Abbott's OCT platforms, physicians use high-resolution images taken directly inside the patient's vessels to accurately measure dimensions and choose a stent that best fits the vessel. OCT is also used to help physicians ensure the stent is fully expanded and is flush against a vessel wall, both important factors in reducing stent failure.
The study seeks to determine whether OCT-guided stent procedures result in larger vessel diameters and whether that will improve clinical outcomes for patients, compared with procedures guided by angiography.
Previous tests of the technology have indicated that stent procedures using OCT imaging resulted in better expansion of stents and greater rates of procedural success, compared with angiography, and also enabled physicians to better detect damage to artery walls that sometimes can be caused by insertion of a stent.
Angiography typically provides a “two-dimensional view of the coronary artery to assess a complex three-dimensional structure,” says Ziad Ali, MD, director of intravascular imaging and physiology at Columbia University Medical Center's Center for Interventional Vascular Therapy, and co-principal investigator of the study.
“Physicians need new technology to help optimize percutaneous coronary intervention, and OCT provides … the ability to look at the artery from the outside-in and the inside-out," Ali adds. "We hope to provide evidence for leading medical organizations to update clinical guidelines for stent implantation based on the results of this study."