OrbusNeich has announced that the first patient has been enrolled in the clinical study in China of its Combo dual therapy stent. The China Recovery Study is designed to evaluate the stent’s performance compared with the Nano stent (Lepu Medical Technology). The first patient was enrolled by Yuan Ming at The First Affiliated Hospital of the Fourth Military Medical University, Xian, China, in May.
The study, a multicentre, prospective, non-inferiority, randomised controlled trial, will enrol 436 patients at up to 20 leading hospitals throughout China. “This trial will deliver significant data that will provide physicians with valuable knowledge to make the best treatment decisions for their patients in China and beyond,” said Steve Rowland, vice president of research and development, OrbusNeich.
The study will enrol patients with de novo stenotic lesions in native coronary arteries. Patients will be randomised 1:1 to the Combo stent or the Nano stent, with follow-up at 30 days, six months, 12 months and annually for up to five years. Additionally, angiographic follow-up will be performed for all subjects at nine months post-procedure. The principal investigator is Tao Ling from the First Affiliated Hospital of the Fourth Military Medical University, Xian, China.
World Health Organization figures estimate that one in five adults in China has a cardiovascular disease with numbers predicted to increase significantly in the coming years based on projected increased incidence of high blood pressure, diabetes, smoking and high cholesterol levels.