St. Jude Medical Says ILUMIEN III Trial Met Primary Endpoint

(RTTNews) - St. Jude Medical Inc. (STJ) announced the ILUMIEN III trial met its primary endpoint demonstrating percutaneous coronary intervention or PCI guided by optical coherence tomography or OCT to be superior to angiography in stent expansion and procedural success and non-inferior to intravascular ultrasound (IVUS) guided-PCI in post-procedure minimal stent area or MSA.

The study enrolled 450 patients at 29 sites in eight countries. It is the first multicenter, prospective, randomized, controlled study to date comparing OCT-guided, IVUS- guided and angiography-guided PCI outcomes.

ILUMIEN III confirmed that OCT-guided PCI: Results in comparable MSA and stent expansion as IVUS-guided PCI; Results in significantly greater stent expansion than angiography-guided PCI, with greater rates of procedural success; and Is superior to IVUS-guided PCI at detecting predictors of major adverse events (major stent malapposition and dissection).