September 27, 2013 — Patient enrollment 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, multicenter, all-comers REMEDEE Registry (Multicenter, Prospective, Clinical Outcomes After Deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio-Engineered Sirolimus Eluting Stent) Post Market Registry) will enroll 1,000 patients at nine European sites. More than 100 patients have already been enrolled.
Study sites will consecutively enroll 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 will include 100 to 150 patients at each of the participating nine high-volume percutaneous coronary intervention centers in France, Latvia, Luxembourg, The Netherlands, Northern Ireland and Spain.
The primary endpoint is clinically driven target vessel failure (TVF) at one-year post procedure, which includes cardiac death, target vessel myocardial infarction (MI) and ischemia driven target vessel revascularization (TVR). Primary endpoint data are expected in the first quarter of 2015.
Secondary endpoints include device and procedural success and adjudicated target lesion failure (TLF) at 30 and 180 days post procedure. Additional secondary endpoints to be evaluated at 30, 180 and 365 days include the components of TVF, defined as cardiac death, target vessel MI and ischemia driven TVR; adjudicated major adverse cardiac events (MACE) as a composite and as each of its components, defined as death, any MI and any revascularization; and adjudicated stent thrombosis. Clinical follow-up will be conducted each year up to five years.
For more information: www.clinicaltrials.gov/ct2/show/NCT01874002