First Patient Enrolled in OrbusNeich's China Recovery Study

July 20, 2015—OrbusNeich announced that the first patient has been enrolled in the clinical study in China of its Combo dual-therapy stent, which combines the company's endothelial progenitor cell capture technology with sirolimus drug elution delivered from a bioresorbable polymer that is completely degraded within 90 days. The China Recovery study is designed to evaluate the Combo device compared to the Nano stent (Lepu Medical Technology Co, Ltd).

The study’s principal investigator is Prof. Tao Ling, MD, from the First Affiliated Hospital of the Fourth Military Medical University in Xian, China. The first patient was enrolled by Yuan Ming, MD, at the First Affiliated Hospital of the Fourth Military Medical University in May 2015.

According to OrbusNeich, the China Recovery study is a multicenter, prospective, noninferiority, randomized controlled trial that will enroll 436 patients at up to 20 leading hospitals throughout China. The study will enroll patients with de novo stenotic lesions in native coronary arteries. Patients will be randomized 1:1 to the Combo dual-therapy stent or the Nano stent. Follow-up will be conducted at 30 days, 6 months, 12 months, and annually for up to 5 years. Additionally, angiographic follow-up will be performed for all patients at 9 months postprocedure.

The China Recovery study’s primary endpoint is in-segment late lumen loss at 9 months postprocedure. Secondary endpoints include device, lesion, and clinical success rates. Other secondary endpoints are device-oriented target lesion failure, defined as a composite of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization at 30 days, 6 months, 12 months, and annually up to 5-year follow-up; the patient-oriented composite endpoint, which includes all-cause death, all myocardial infarctions, or any revascularization at 30 days, 6 months, 12 months, and annually up to 5-year follow-up; in-stent late lumen loss at 9 months postprocedure; in-stent and in-segment binary restenosis rates at 9 months postprocedure; in-stent and in-segment minimal lumen diameter at 9 months postprocedure; and, finally, definite and probable stent thrombosis in acute, subacute, late, and very late periods per Academic Research Consortium definition criteria, advised the company.