Enrolment Begins In Combo Dual Therapy Stent Pivotal Trial in Japan
The patient enrolment has been initiated in Japan in the pivotal trial of OrbusNeich's investigational Combo dual therapy stent ( Combo stent) employing a single Japan-US protocol conducted as a global clinical trial 'proof-of-concept' under the framework of the joint Japan-US Harmonisation by Doing initiative. The first patient was enrolled at Shonan Kamakura General Hospital, Japan, by Dr Shigeru Saito, the Vice Director of the hospital and Co-Principal Investigator of the study.
The randomised, multicentre HARMONEE (Harmonized Assessment by Randomized, Multi-centre Study of OrbusNEich's Combo StEnt) study is designed to enrol 572 patients at up to 50 sites in Japan and the US to support the company's planned application for Shonin approval in Japan and to meet the pilot trial requirements in the US patients presenting with ischaemic coronary disease and non-ST segment myocardial infarction (MI) will be randomised one-to-one to treatment with a Combo stent or an everolimus-eluting stent comparator.
The HARMONEE study design consists of three cohorts, each with equal number of patients receiving either the Combo or the control stent. The first cohort includes 30 patients who will undergo assessment by fractional flow reserve (FFR) and quantitative coronary angiography (QCA) at 12 months and optical coherence tomography (OCT) at six and 12 months. The second cohort consists of 110 patients who will undergo assessment by FFR, QCA and OCT at 12 months. The third cohort of 432 patients will undergo assessment by FFR and QCA at 12 months.