Durham, N.C.-based Micell said the Dessolve III trial, a prospective, randomized, balanced, controlled, single-blind, multi-center study is slated to enroll up to 1,400 "real world, all-comers" patients in Europe.
Like the Xience stent, the MiStent device elutes an anti-restenosis drug called sirolimus (Xience elutes everolimus). But unlike its predecessor, MiStent’s polymer coating holding the drug is designed to dissolve over time, leaving a cobalt chromium stent behind.
The new study’s primary endpoint is a non-inferiority comparison of a device-oriented composite endpoint or target lesion failure of the MiStent group versus the Xience group at 12 months post-procedure, Micell said.
Dessolve III will also include an optical coherence tomography sub-study superiority analysis of 60 patients at 6 and 24 months to evaluate the progression of in-stent percent volume obstruction and frequency of neoatheroma formation over time, the company said.
"We are conducting Dessolve III to further support the importance of MiStent in clinical practice, building on the 4-year results from the Dessolve I and Dessolve II studies that we plan to report later this year," chairman & CEO Arthur Benvenuto said in prepared remarks. "As a new class of drug-eluting stent that allows the drug to remain in the tissue for an extended period – well beyond a rapidly absorbing polymer – MiStent has the potential to offer meaningful clinical and economic benefits to patients and the healthcare system."
Micell, which won CE Mark approval in the European Union in June 2012 for the MiStent, inked a deal that will see Stentys SA (EPA:STNT) assume exclusive distribution in Europe. Stentys is planning a controlled release in Western Europe will a full commercial launch slated for the 2nd half of the year "in selected countries within Europe, Middle East, South-East Asia and Latin America," according to a press release.
"We are very excited about the early start of this ambitious all-comers study of MiStent SES against Xience at the time when we are introducing the product in Europe," Stentys CEO Gonzague Issenmann said in a statement. "MiStent SES is redefining drug-delivery to match vessel response, and it is an excellent fit in our portfolio for treating complex coronary artery disease."