Conor to expand pivotal DES (drug-eluting stent) trial:
This article was originally published in Clinica
Executive Summary
The US FDA has given Conor Medsystems approval to expand enrolment in its pivotal drug-eluting stent (DES) trial to the full cohort of 1,700 patients at up to 85 sites. The COSTAR II trial, in which the first patient was enrolled in May 2005, is comparing the firm's cobalt chromium paclitaxel-eluting stent, CoStar, with Boston Scientific's market-leading DES, Taxus. The devices are being used to treat de novo lesions in patients with single or multi-vessel coronary artery disease. The study's primary endpoint is major adverse cardiac events (MACE) at eight months. The Menlo Park, California firm expects to use the trial's data to support a US marketing application for CoStar.