Medical device developer Medtronic said that enrollment has begun in its Endeavor IV clinical trial, the final phase of its Endeavor clinical program to be used in support of a Food and Drug Administration premarket approval (PMA) application.
The Endeavor IV clinical trial is a randomized single-blind trial evaluating the safety and efficacy of the Endeavor drug-eluting coronary stent as compared to the Taxus paclitaxel-eluting coronary stent system from Natick, MA-based Boston Scientific, according to Minneapolis-based Medtronic.
The study will include approximately 1,548 patients randomized one-to-one against the Taxus stent, and will be performed at approximately 80 centers in the U.S. and Canada, Medtronic said. The primary end point of the trial is target-vessel failure at nine months, with a secondary end point of major adverse cardiac events at 30 days. The trial includes angiographic and intravascular ultrasound follow-up at eight months for a subset of 328 patients, the company said.
By AuntMinnie.com staff writers
April 13, 2005
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