Patient enrolment has been initiated in a post-market registry for the Combo dual-therapy stent to evaluate its long-term safety and performance in routine clinical practice. The prospective, multicentre, all-comers REMEDEE registry is expected to enrol 1,000 patients.
The REMEDEE (Multicenter, prospective, clinical outcomes after deployment of the abluminal sirolimus coated bio-engineered stent post-market) registry has begun enrolment at nine European sites. According to the company, more than 100 patients have already been enrolled.
Study sites will consecutively enrol patients in whom Combo-stent placement is attempted to treat a coronary lesion in the setting of routine clinical care. This flash-type patient recruitment is expected to include 100 to 150 patients at each of the participating nine high-volume percutaneous coronary intervention centres in France, Latvia, Luxembourg, The Netherlands, Northern Ireland and Spain.
The primary endpoint is clinically driven target vessel failure at one year post procedure, which includes cardiac death, target vessel myocardial infarction and ischaemia driven target vessel revascularisation. Primary endpoint data are expected in the first quarter of 2015.
“The Combo dual-therapy stent is a truly innovative device that addresses the challenge of delayed arterial healing caused by monotherapy drug-eluting stents by combining the antiproliferative property of a drug-eluting stent with a pro-healing antibody coating technology,” said Robbert de Winter of the Academic Medical Center, Amsterdam, The Netherlands, and principal investigator of the study.
Robert N Wood Jr, senior vice president and chief commercial officer of OrbusNeich, said, “Now that CE mark has been received for the Combo dual-therapy stent, the REMEDEE registry will help to establish the long-term safety and performance for the Combo stent in a real-world patient population.”
Secondary endpoints include device and procedural success and adjudicated target lesion failure at 30 and 180 days post procedure. Additional secondary endpoints to be evaluated at 30, 180 and 365 days include the components of target vessel failure, defined as cardiac death, target vessel myocardial infarction and ischaemia driven target vessel revascularisation; adjudicated major adverse cardiac events (MACE) as a composite and as each of its components, defined as death, any myocardial infarction and any revascularisation; and adjudicated stent thrombosis. Clinical follow-up will be conducted each year up to five years.