Micell Technologies has begun enrolling patients in DESSOLVE C: a prospective, single-blind, multicentre, randomised, controlled clinical trial to demonstrate the efficacy and safety of its MiStent SES sirolimus-eluting absorbable polymer coronary stent system.
MiStent SES is used to treat patients with coronary artery disease, and its performance will be compared, in this study, to Tivoli bioabsorbable polymer-based sirolimus-eluting stent. Ya-Ling Han, vice president of the General Hospital of Shenyang Military Region, is the principal investigator. Xu Bo, director of the Catheterization Laboratory at the National Center for Cardiovascular Diseases and Fu Wai Hospital, and Yang Yuejin, vice president of the Cardiovascular Institute and Fu Wai Hospital are co-principal investigators. DESSOLVE C, intended to support regulatory approval of MiStent SES in China, is being sponsored by Hefei Life Science Technology in conjunction with Micell.
The primary endpoint for this trial is nine-month in-stent late lumen loss. The study will compare nine-month angiographic and 12-month clinical outcomes between MiStent SES and Tivoli, a locally-favoured bioabsorbable coated stent developed in China. Candidates for trial participation suffer from symptomatic coronary artery disease, including those with chronic stable angina, silent ischaemia, acute coronary syndromes and those who qualify for percutaneous coronary interventions. Enrolment is expected to include about 428 patients randomised to MiStent SES or Tivoli at approximately 18 clinical sites within China.
An angiographic sub-study will evaluate the degree of late lumen loss progression at three years post-procedure. The sub-study data are intended to confirm a finding in the preceding MiStent SES first-in-human study, that MiStent SES has a significant reduction in the degree of late lumen loss progression in contrast to what has been demonstrated in other drug-eluting stents.
“MiStent SES is redefining drug-delivery to match vessel response, and will bring this valuable product to the Chinese patients to treat their coronary artery disease,” said Han. “Long-term outcomes, especially three-year angiographic follow-up, will provide us very important information about the MiStent SES.”
The morbidity and mortality of cardiovascular disease are continuing to increase, and pose a significant health risk, in China. As of 2011, there were around 230 million patients with cardiovascular disease, leading to three million deaths each year. Arthur J Benvenuto, chairman and chief executive officer of Micell, said, “Even given recent advancements in medicine and healthcare, patients could gain additional benefit from a new class of drug-eluting stent that allows the drug to remain in the diseased tissue for an extended period.”
In connection with the study, MiStent SES will be distributed exclusively by Hefei in China, Hong Kong and Macau. MiStent SES has received CE mark in the European Union, and already is available there through Micell’s partner, Stentys, which introduced MiStent SES earlier this year to Western Europe via a controlled launch. This will be followed by a full commercial launch in the second half of 2015 in selected countries within Europe, the Middle East, South-East Asia and Latin America.