Conor Receives Conditional IDE to Begin COSTAR II Trial

The FDA has given Conor Medsystems conditional approval of an investigational device exemption to begin its COSTAR II pivotal clinical trial to support U.S. regulatory approval of the company's CoStar stent.

The COSTAR II (CObalt chromium STent with Antiproliferative for Restenosis II) trial is designed to enroll approximately 1,700 patients at up to 70 U.S. and 15 international sites. The trial will be a randomized, single-blind, noninferiority study comparing Conor's CoStar cobalt chromium paclitaxel eluting stent with Boston Scientific's Taxus Express2 drug-eluting stent in the treatment of de novo lesions in patients with single or multivessel coronary artery disease.

Patients will be asymmetrically randomized between the CoStar cobalt chromium paclitaxel-eluting stent and the control stent with clinical follow-up at 30 days and at eight months. Also, a 350-patient subset will undergo follow-up angiography at nine months.