Medical device manufacturer Medtronic has received FDA clearance to begin the third round of clinical trials on its drug-eluting coronary stent Endeavor.
The third-round trial is an equivalency study including 436 patients (327 receiving the Endeavor stent) with a primary endpoint of late lumen loss at eight months. Secondary endpoints include target lesion revascularization, target vessel revascularization, and target vessel failure rates at nine months and angiographic binary restenosis rate at eight months, according to the company.
In addition, the safety and efficacy of the stent will compared to the Cypher sirolimus-eluting stent marketed by Cordis, a Johnson & Johnson subsidiary, Medtronic said.
By AuntMinnie.com staff writersFebruary 12, 2004
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