The OPTIMIZE randomized trial to assess safety and efficacy of the Svelte IDS and RX Sirolimuseluting coronary stent Systems for the Treatment of atherosclerotic lesions: Trial design and rationale

摘要

Background Coronary stenting without angioplasty pretreatment (direct stenting) may simplify procedures in appropriate lesions. Direct stenting is facilitated by smaller profile coronary stent platforms. The present study was designed for regulatory approval of a novel drug-eluting coronary stent and incorporates both randomized comparison for non-inferiority to an approved predicate device as well as a nested evaluation of subjects eligible for direct stenting.