Conor Medsystems has received FDA approval to expand enrollment in its COSTAR II clinical trial comparing the firm's investigational CoStar drug-eluting stent with Boston Scientific's Taxus Express2 drug-eluting stent.
The FDA's decision allows Conor to expand enrollment to the full cohort of 1,700 patients at up to 85 sites, the company said. Conor received conditional investigational device exemption approval from the FDA in March 2005 to begin the trial at a limited number of sites. The first patient enrolled in the study in May 2005, the firm said.
The expanded COSTAR II U.S. pivotal clinical trial (CObalt chromium STent with Antiproliferative for Restenosis) is a randomized, single-blind, non-inferiority study comparing the Conor's cobalt chromium paclitaxel-eluting stent with the Taxus Express2 in the treatment of de novo lesions in patients with single or multi-vessel coronary artery disease.
The primary endpoint for the study is 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. Data from this trial will support Conor's application for U.S. regulatory approval of the CoStar stent, the firm said.
In contrast to conventional surface-coated stents, Conor's stents are designed for vascular drug delivery. The firm's drug-eluting stent incorporates hundreds of small holes, each acting as a reservoir into which drug-polymer compositions can be loaded. The CoStar stent uses bioresorbable polymers that are absorbed by the body after the drug is released, leaving no permanent residual polymers at the target site.
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