OrbusNeich has announced that the first US patient has been enrolled in the HARMONEE (Harmonised assessment by randomised, multicentre study of OrbusNeich’s COMBO stent) study. The study is being conducted under the framework of the joint Japan-USA “harmonisation-by-doing” (HBD) initiative and will support the company’s planned application for Shonin approval in Japan and to meet the feasibility trial requirements in the USA.
“We are delighted to confirm that the enrolment process for the HARMONEE study in the USA has begun,” said Steve Rowland, Vice President Research & Development, OrbusNeich. “With a unique Japan-USA collaboration involving co-enrolment in both countries and a single Japan-USA protocol, this regulatory harmonisation will help bring forward new options for patients with coronary artery disease in both countries.”
The study is a multicentre, single-blind, randomised, active-controlled, clinical trial in percutaneous coronary intervention (PCI) subjects. Several additional sites are open and actively screening.
The HARMONEE study will enrol 572 patients at up to 50 study locations in Japan and the USA. The first patient was enrolled at Shonan Kamakura General Hospital, Japan in February 2014. The study’s endpoint is a comparison of clinically driven target vessel failure (TVF), defined as cardiac death, target vessel myocardial infarction or ischaemia-driven target vessel revascularisation (TVR) by percutaneous or surgical methods. All patients will undergo fractional flow reserve (FFR) or angiography to determine ischaemia-driven TVR.
“The enrolment of the first US patient marks a key milestone in the initiation of the US investigational device exemption portion of the HARMONEE study,” said Roxana Mehran, director of Interventional Cardiovascular Research and Clinical Trials, Mount Sinai Medical Center, USA, and US principal investigator. “This randomised controlled trial is the first to use both physiologic and anatomic assessment of the long-term result of the stent procedure, as well as using high-resolution imaging of vascular healing, and it will provide important data that will inform the care of patients with coronary artery disease.”