Micell Technologies said today it launched a Chinese trial of its MiStent SES sirolimus eluting absorbable polymer coronary stent system used to treat coronary artery disease.
The prospective, single-blind, multi-center, randomized, controlled Dessolve C trial looks to enroll 428-patients in a study comparing the company’s MiStent SES and the Tivoli bioabsorbable coated stent, which Durham, N.C.-based Micell said is developed and locally favored in China.
“The morbidity and mortality of cardiovascular disease are continuing to increase, and pose a significant health risk, in China. As of 2011, there were about 230 million patients with cardiovascular disease, leading to 3 million deaths each year. 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,” CEO Arthur Benvenuto said in a press release.
The study will compare 9 and 12-month clinical outcomes of patients implanted with the stents, the company said. The trial is intended to support Chinese regulatory approval of the stent, and is being sponsored by Hefei Life Science Technology, Micell said.
“We are very excited about starting the randomized, controlled study in China and working with Micell to bring MiStent SES to the Chinese market. 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. Long-term outcomes, especially three-year angiographic follow-up will provide us very important information about the MiStent SES,” principal investigator Dr. Ya-Ling Hanof the Shenyang Military Region said in prepared remarks.
A different angiographic sub-study will examine the degree of late lumen loss at 3 years post-procedure, Micell said. The sub-study looks to evaluate whether the MiStent SES shows a reduction in late lumen loss compared to other drug related stents.
In March, Micell launched an all-comers trial to compare its MiStent with the Xience drug-eluting stent made by Abbott (NYSE:ABT). Named the Dessolve III trial, the study is slated to enroll up to 1,400 “real world, all-comers” patients in Europe.