Study Focus:

HARMONEE is a multi-center, single-blind, active-controlled, clinical trial evaluating the effectiveness of the Combo Plus Coronary Stent versus the Everolimus Eluting Stent (EES) in percutaneous coronary intervention. Randomized patients will receive the Combo stent as the investigational treatment arm or EES as the active-control arm.

 

Study Population:

572 patients enrolled at 50 sites in Japan and the U.S. with ischemic coronary disease and NSTEMI acute coronary syndrome.

 

Clinical Events Classification Insight:

Duke Clinical Research Institute provided full-service project support including clinical events classification for 184 events adjudicated. This helped achieve the study’s primary endpoint for Japanese approval of the of the COMBO Plus Coronary Stent, which was announced September 2019. Event types adjudicated included death, myocardial infarction, target vessel revascularization, target lesion revascularization, stroke/TIA, and stent thrombosis.