Medtronic Starts U.S. Arm of Global Stent Study

Medtronic has begun enrolling patients for U.S. sites in its PROTECT study, a global trial comparing the safety of its Endeavor drug-eluting stent with Johnson & Johnson’s Cypher stent.

Under way in Europe, the study will recruit a total of 8,800 patients at more than 200 medical centers globally. It will focus primarily on stent thrombosis, a rare but serious adverse event in which a blood clot forms inside the stent, which can cause a heart attack or death, Medtronic said.

The trial will measure differences in the rates of stent thrombosis between the two stents with the primary endpoint being the recurrence of overall thrombosis at three years. Enrollment is expected to be complete by December.