Clinical trial to assess OCT for more-precise stent implantation
The trial will evaluate the company's OCT imaging in patients with high-risk, complex coronary artery disease.
Abbott (Abbott Park, IL) has initiated a clinical trial evaluating long-term outcomes of patients who undergo stent implantation guided by optical coherence tomography (OCT) compared to a common x-ray-guided technique called angiography. The ILUMIEN IV trial is a large-scale randomized global study using the company's OCT imaging in patients with high-risk, complex coronary artery disease. Patients in the study will be randomized to either OCT-guided or traditional angiography to guide placement of one or more XIENCE everolimus-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 dimension 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, which are both important factors in reducing stent failure.
The ILUMIEN IV trial will enroll up to 3650 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—allowing increased blood flow—and whether this will improve clinical outcomes for patients compared to stent procedures guided by angiography. Patients with complex disease may have multiple, or totally blocked, arteries, or other diseases such as diabetes, and these patients account for an increasing number of cases.
The ILUMIEN IV trial's focus on high-risk patients will build on findings from the previous ILUMIEN series of trials, which showed that stent procedures using OCT imaging resulted in superior stent expansion and greater rates of procedural success compared to angiography, and non-inferiority to intravascular ultrasound (IVUS) in post-procedure minimal stent area (MSA). Those trials also showed that use of OCT imaging enabled physicians to better detect damage to artery walls, called dissection, which sometimes happens during the placement of a stent compared to IVUS or angiography, which could then be repaired as necessary.