Micell Technologies has begun patient enrolment in DESSOLVE III, a randomised, controlled clinical trial comparing the MiStent sirolimus eluting absorbable polymer coronary stent system with the Xience everolimus eluting coronary stent system.
Robbert J de Winter, Department of Cardiology, Academic Medical Center, Amsterdam, the Netherlands, enrolled the first patient in the study. This clinical investigation is being conducted by the European Cardiovascular Research Institute, Rotterdam, the Netherlands, and is supported by Micell in conjunction with Stentys, the Paris-based medical technology company that is Micell’s distribution partner for MiStent.
DESSOLVE III is a prospective, randomised, balanced, controlled, single-blind, multicentre study comparing clinical outcomes between MiStent and Xience in a real world, all-comers patient population. Candidates for trial participation suffer from symptomatic coronary artery disease, including those with chronic stable angina, silent ischaemia, acute coronary syndromes, and qualify for percutaneous coronary interventions. Enrolment will include 1,400 patients randomised to MiStent or Xience at 17 clinical sites in Europe. The primary endpoint for this trial 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.
DESSOLVE III will also include an optical coherence tomography sub-study evaluation of 60 patients at six and 24 months post-treatment to evaluate and compare for superiority of MiStent against Xience in the progression of in-stent per cent volume obstruction and frequency of neoatheroma formation over time.
Arthur J Benvenuto, chairman and chief executive officer of Micell said, “We are conducting DESSOLVE III to further support the importance of MiStent in clinical practice, building on the four-year results from the DESSOLVE I and DESSOLVE II studies that we plan to report later this year. 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.”
MiStent has received CE mark in the European Union, and will be distributed exclusively by Stentys around the world with the exception of the USA, Canada, China, South Korea and Japan. Stentys plans a controlled launch in Western Europe followed by a full commercial launch in the second half of 2015 in selected countries within Europe, Middle East, Southeast Asia and Latin America.
“We are very excited about the early start of this ambitious all-comers study of MiStent against Xience at the time when we are introducing the product in Europe,” said Gonzague Issenmann, chief executive officer of Stentys. “MiStent is redefining drug-delivery to match vessel response, and it is an excellent fit in our portfolio for treating complex coronary artery disease.”