US-based biomedical firm Micell Technologies has started patient enrolment in DESSOLVE III, a randomised, controlled clinical trial comparing MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System to Xience Everolimus Eluting Coronary Stent System (Xience).
First patient in the all-comers trial was enrolled by Robbert Winter, Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands.
The clinical trial is being conducted by the European Cardiovascular Research Institute (ECRI) with support from Micell in conjunction with Stentys, a French medical technology firm and Micell’s distribution partner for MiStent.
The prospective, randomised, balanced, controlled, single-blind, multi-centre DESSOLVE III trial is comparing clinical outcomes between MiStent SES and Xience.
In order to participate in the trial, candidates should have symptomatic coronary artery disease, including those with chronic stable angina, silent ischemia, acute coronary syndromes and qualify for percutaneous coronary interventions.
Approximately 1,400 patients will be enrolled in the trial and they will be randomised to MiStent SES or Xience at 17 clinical sites in Europe.
The trial’s primary endpoint is a non-inferiority comparison of a device-oriented composite endpoint (DOCE) or target lesion failure (TLF) of the MiStent SES group versus the Xience group at 12 months post-procedure.
Micell CEO Arthur Benvenuto 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."
The trial will also include an optical coherence tomography (OCT) sub-study evaluation of 60 patients at six and 24 months post-treatment.
The OCT sub-study is being conducted to assess and compare for superiority of MiStent SES against Xience in the progression of in-stent percent volume obstruction and frequency of neo atheroma formation over time.
In the European Union, MiStent SES received CE Mark and it will be distributed exclusively by Stentys worldwide with the exception of the US, Canada, China, South Korea and Japan.
Stentys is currently planning 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, South East Asia and Latin America.
The company said that MiStent SES is designed to optimise healing in patients with coronary artery disease.