Dessolve III is a prospective, single-blind (patient), randomized, controlled, multicenter trial. Approximately 17 sites in Europe will participate. The enrollment required for this trial is 1,400 patients and as this is a 1:1 randomization, it is anticipated that 700 patients will be treated with the MiStent and 700 patients will be treated with the control XIENCE.
Clinical data will be adjudicated by an independent Clinical Event Committee. An independent Data Safety and Monitoring Board (DSMB) will monitor the individual and collective safety of the patients in the trial during enrolment phase.
The Principal Investigators are Professor P.W. Serruys (the Netherlands), Professor W. Wijns (Belgium) and Professor R. de Winter (the Netherlands).
The European Cardiovascular Research Institute (ECRI) acts as sponsor for the Dessolve III trial. ECRI is being supported by scientific grants from Stentys SA and Micell Technologies.