Cardiac technology developer St. Jude Medical has begun its Ilumien III clinical trial to gauge the clinical benefits of its Ilumien optical coherence tomography (OCT) technology for guiding stent implantation.
The prospective, international, randomized trial will compare OCT-guided stent implantation to implantation guided by intravascular ultrasound (IVUS) or angiography alone, according to the vendor. Up to 420 patients at up to 35 sites in Europe, the U.S., and Japan will be enrolled in the trial, which will provide percutaneous coronary intervention (PCI) for stable or unstable angina, silent ischemia, or ST-segment elevation myocardial infarction (STEMI) or non-STEMI due to arterial blockages, St. Jude Medical said.
Patients will be randomized to receive PCI with either OCT, angiography, or IVUS; the primary end point will be the degree of minimum stent area achieved. The first patient in the trial underwent PCI guided by the firm's Optis PCI optimization system, St. Jude Medical said.
