Micell Technologies has started the enrollment of patients in DESSOLVE C trial in China, which is designed to evaluate the efficacy and safety of its MiStent SES Sirolimus Eluting Absorbable Polymer Coronary Stent System.
MiStent SES has been developed to treat patients with coronary artery disease (CAD). Sponsored by Hefei Life Science Technology in conjunction with Micell, DESSOLVE C trial will support regulatory approval of MiStent SES in China.
Micell chairman and CEO Arthur Benvenuto said: "The morbidity and mortality of cardiovascular disease are continuing to increase, and pose a significant health risk, in China."
The prospective, single-blind, multi-center, randomized and controlled clinical trial will compare the performance of MiStent SES against Tivoli Bioabsorbable Polymer Based Sirolimus-Eluting Stent.
According to the firm, the primary endpoint of the study will be nine-month in-stent late lumen loss.
In the trial, around 428 patients will be randomized to MiStent SES or Tivoli at around 18 clinical sites within China.
In addition, an angiographic sub-study will assess the degree of late lumen loss progression at three years post-procedure. This data is intended to confirm a finding in the preceding MiStent SES First-in-Human study.
Hefei will exclusively distribute MiStent SES in China, Hong Kong and Macau for the trial.
MiStent SES received CE mark approval in the European Union and is available through its partner STENTYS.