St. Jude Medical Reaches Primary Endpoint for OCT Trial

A trial undertaken by medical device company St. Jude Medical Inc. has met its primary endpoint as the first multicenter, prospective, randomized, controlled study comparing optical coherence tomography- (OCT), intravascular ultrasound- (IVUS) and angiography-guided outcomes for percutaneous coronary intervention (PCI).

The ILUMIEN III study demonstrated PCI guided by OCT to be superior to angiography in stent expansion and procedural success and non-inferior to IVUS-guided PCI in post-procedure minimal stent area (MSA). Physicians employed the St. Jude Medical OPTIS Integrated and ILUMIEN OPTIS PCI optimization systems, along with the Dragonfly imaging catheters designed for high-resolution imaging, to assess vessel and lesion characteristics, size stents and optimize stent placement in patients randomized to OCT-guided stent implantation.

St. Jude Medical Optical Coherence Tomography (OCT) Software features automated measurements, co-registered angiography views and new stent deployment features. Courtesy of St. Jude Medical Inc.

“These results provide further evidence of the importance of imaging in PCI procedures,” said Dr. Ziad A. Ali, associate director of translational medicine at the Columbia University Medical Center’s Center for Interventional Vascular Therapy and a principal investigator of the ILUMIEN III study. “Minimal stent area is widely considered the most important factor for circumventing both early and late major cardiovascular events. Now we know that OCT-guided PCI achieves similar MSA results to IVUS-guided PCI and results in significantly greater stent expansion to angiography.”

St. Jude Medical plans to expand its research next year.

“These results demonstrate that OCT is an important imaging option to achieve optimal stent deployment to advance the care of patients with coronary artery disease,” said Philip Ebeling, vice president and chief technology officer at St. Jude Medical. “Optical coherence tomography has a superior resolution to detect predictors that can contribute to major adverse events and thus can facilitate the treatment of those conditions, if necessary, to minimize the likelihood of their occurrence.”

St. Jude is a developer of medical devices that aim to transform the treatment of heart failure, atrial fibrillation, neuromodulation, traditional cardiac rhythm management and other cardiovascular issues.