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www.fdanews.com/articles/171906-st-jude-medical-launches-oct-guided-stent-implant-trial

St. Jude Medical Launches OCT-Guided Stent Implant Trial

June 30, 2015

St. Jude Medical has initiated its multicenter, international clinical trial evaluating optical coherence tomography guidance during stent implantation.

The Ilumien III study will compare OCT-guided stent implantation to implantation guided by intravascular ultrasound or angiography alone. The St. Paul, Minn., devicemaker claims IVUS and angiography provide lower picture resolution than that of OCT during intravascular assessments and percutaneous coronary interventions.

The trial plans to enroll up to 420 patients across 35 sites, with a primary endpoint of degree of minimum stent area achieved, the company said Tuesday.

St. Jude’s Optis Integrated and Ilumien Optis PCI optimization systems will be used in the study. — Jason Scott