Conor received conditional investigational device exemption approval from the FDA to begin the trial in a limited number of sites in March 2005. The first patient was enrolled in the study in May.
The trial compares Conor’s CoStar cobalt chromium paclitaxel-eluting stent with Boston Scientific’s Taxus Express2 drug-eluting stent in the treatment of new lesions in patients with single or multi-vessel coronary artery disease.
The primary endpoint for the study is a reduction in major adverse cardiac events at eight months. Other endpoints include target lesion revascularization, binary restenosis, and in-segment and in-stent late loss as measured by angiography.
Conor’s drug-eluting stent incorporates hundreds of small holes, each acting as a reservoir into which drug-polymer compositions can be loaded. In addition, the stent uses bioresorbable polymers that are absorbed by the body after the drug is released, leaving no permanent residual polymers at the target site.