Medtronic has initiated an international study comparing its Endeavor Resolute zotarolimus-eluting coronary stent with Abbott Laboratory’s Xience V everolimus-eluting coronary stent.
The first implants in the RESOLUTE III all-comers trial took place in Europe during the last two weeks.
RESOLUTE III is the pivotal trial for the Endeavor Resolute drug-eluting stent (DES) and one part of the comprehensive RESOLUTE clinical program, according to the Minneapolis-based company.
Medtronic said the RESOLUTE III will randomize approximately 2,300 patients, in a one-to-one manner, to the Endeavor Resolute or Xience stent at 15 to 20 international medical centers in countries where both stents are commercially available. The primary endpoint for RESOLUTE III is target lesion failure, cardiac death, MI and target lesion revascularization at one year as defined by the Academic Research Consortium.
The teams of Stephan Windecker, MD, of University Hospital Bern in Switzerland, one of three principal investigators, and William Wijns, MD, of the Cardiovascular Centre Aalst in Belgium, enrolled the first patients in RESOLUTE III on April 30. Sigmund Silber, MD of the Heart Catheterization Centre in Munich, Germany, and Patrick Serruys, MD, of the Heartcenter, in Rotterdam, Netherlands, are the other principal investigators.