MEDTRONIC ANNOUNCES LARGEST CLINICAL STUDY EVALUATING DRUG-ELUTING STENT SAFETY

Medtronic said Oct. 19 it will begin the largest-ever clinical trial to assess the safety of its Endeavor drug-eluting coronary stent in comparison with a competitor's device.

The PROTECT trial will compare Medtronic's Endeavor zotarolimus-eluting stent to Johnson & Johnson's Cypher sirolimus-eluting stent. The study will enroll approximately 8,000 patients at 200 clinical centers in Europe and other international markets, Medtronic said.

The primary endpoint for the PROTECT study will be overall stent thrombosis (blood clotting), with secondary endpoints that include death and nonfatal myocardial infarction along with customary clinical efficacy endpoints, the firm said.