Medtronic starts U.S. arm of global stent study

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Medtronic has initiated the first investigational sites in the United States to participate in PROTECT, the company’s global study comparing the Endeavor and Cypher drug-eluting stents on key safety metrics, including stent thrombosis.

Carlos Mego, MD, and his team at Doctors Hospital at Renaissance in Edinburg, Texas, enrolled the first U.S. patient in PROTECT last week, according to the Minneapolis-based company.

Initiated in Europe in May 2007, Medtronic said that PROTECT will enroll a total of 8,800 patients, equally randomized to its Endeavor zotarolimus-eluting coronary stent or Johnson & Johnson’s Cypher sirolimus-eluting coronary stent, at more than 200 medical centers globally. Enrollment through July stands at nearly 5,500 patients.

Collectively, the company said data from PROTECT augments the ENDEAVOR clinical program, which involves more than 21,000 patients; more than 15,000 of the patients will have received an Endeavor stent in the ENDEAVOR trial.

PROTECT sites in the United State will provide the FDA with U.S.-specific data on the post-market experience with the Endeavor stent, which received FDA approval Feb. 1, according to the company. The U.S. sites will enroll a minimum of 1,000 patients who receive Endeavor stents through PROTECT or, if necessary, through a nonrandomized continued-access arm.