Micell Begins DESSOLVE C Trial of MiStent SES in China

July 22, 2015—Micell Technologies, Inc. announced the commencement of patient enrollment for the DESSOLVE C clinical trial in China for the company’s MiStent SES sirolimus-eluting absorbable polymer coronary stent system for the treatment of patients with coronary artery disease (CAD). The DESSOLVE C trial is intended to support regulatory approval of the MiStent SES in China.

In DESSOLVE C, the performance of the MiStent SES device will be compared to the Tivoli bioabsorbable polymer-based, sirolimus-eluting stent (Essen Technology Company, Ltd). Tivoli is a locally favored device that was developed in China, advised Micell.

The trial is being sponsored by Hefei Life Science Technology Co., Ltd. in conjunction with Micell. In connection with the study, the MiStent SES device will be distributed exclusively by Hefei in China, Hong Kong, and Macau.

According to the company, the prospective, single-blind, multicenter, randomized, controlled DESSOLVE C clinical trial is intended to demonstrate the efficacy and safety of the MiStent SES device. The trial will enroll patients with symptomatic CAD, including those with chronic stable angina, silent ischemia, and acute coronary syndromes who qualify for percutaneous coronary interventions. Enrollment is expected to include approximately 428 patients randomized to MiStent SES or Tivoli at approximately 18 clinical sites within China.

For the trial’s primary endpoint of 9-month in-stent late lumen loss, investigators will compare 9-month angiographic and 12-month clinical outcomes between MiStent SES and Tivoli.

An angiographic substudy will evaluate the degree of late lumen loss progression at 3 years postprocedure. The substudy data are intended to confirm a finding in the preceding MiStent SES first-in-human study that the MiStent SES device significantly reduced the degree of late lumen loss progression in contrast to what has been demonstrated in other drug-eluting stents.

Prof. Ya-Ling Han, MD, is the trial’s Principal Investigator, with Xu Bo, MBBS, and Yang Yuejin, MD, serving as Coprincipal Investigators.

Prof. Han is Vice President of the General Hospital of Shenyang Military Region in Shenyang, China. Dr. Bo is Director of the Catheterization Laboratory at the National Center for Cardiovascular Diseases and Fu Wai Hospital in Beijing. Dr. Yuejin is Vice President of the Cardiovascular Institute and Fu Wai Hospital.

The MiStent SES device has received European CE Mark approval and is marketed in the European Union through Stentys. Stentys introduced the MiStent SES device in Western Europe earlier this year via a controlled launch, which will be followed by a full commercial launch in the second half of 2015 in selected countries within Europe, the Middle East, Southeast Asia, and Latin America.