United States Enrollment Begins in HARMONEE Study of OrbusNeich's Combo Stent

May 18, 2015—OrbusNeich announced that the first patient in the United States has been enrolled in the HARMONEE (Harmonized Assessment by Randomized, Multicenter Study of OrbusNeich’s Combo Stent) study, which is evaluating the company’s Combo dual-therapy stent.

The HARMONEE trial commenced in Japan in February 2014, with the first patient enrolled at Shonan Kamakura General Hospital in Kamakura, Kanagawa Prefecture. The study is being conducted under the framework of the joint Japan-United States Harmonization-By-Doing initiative and will support the company’s planned application for Shonin regulatory approval in Japan and to meet the feasibility trial requirements in the United States. 

The Combo stent is designed to repair vessel injury and regenerate endothelium by accelerating endothelial coverage and controlling neointimal proliferation. The device combines the company’s endothelial progenitor cell-capturing technology and sirolimus elution, delivered from a bioresorbable polymer that is completely degraded within 90 days.

According to OrbusNeich, HARMONEE is a multicenter, single-blind, randomized, active-controlled clinical trial in percutaneous coronary intervention patients. Several additional sites are open and actively screening. The study will enroll 572 patients at up to 50 study locations in Japan and the United States. 

The study’s endpoint is a comparison of clinically driven target vessel failure, defined as cardiac death, target vessel myocardial infarction, or ischemia-driven target vessel revascularization by percutaneous or surgical methods. All patients will undergo fractional flow reserve or angiography to determine ischemia-driven target vessel revascularization.

Roxana Mehran, MD, is the United States Principal Investigator of the study. In OrbusNeich’s press release, Dr. Mehran commented, “The enrollment of the first United States patient marks a key milestone in the initiation of the US investigational device exemption portion of the HARMONEE study. This randomized 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.” Dr. Mehran is Director of Interventional Cardiovascular Research and Clinical Trials at Mount Sinai Medical Center in New York, New York.