Micell Technologies has started DESSOLVE J trial in Japan, designed to compare MiStent SES sirolimus eluting absorbable polymer coronary stent system against XIENCE V Everolimus eluting coronary stent system.
Shonan Kamakura General Hospital vice director Dr Shigeru Saito is the principal investigator of the randomized, balanced, controlled, double-blind and multi-center study.
MiStent has been developed to enhance healing and clinical performance in patients with coronary artery disease. It received CE mark approval, while not approved in the US.
Micell's patented supercritical fluid technology will enable controlled coating of the drug and polymer, whereby the drug is applied to a bare-metal stent in a dry powder and crystalline form.
According to the company, DESSOLVE J is an all-comers trial with a primary endpoint of target lesion failure (TLF) comparing 12-month clinical outcomes between MiStent and Xience.
Patients in the trial suffer from symptomatic coronary artery disease, including those with chronic stable angina, silent ischemia, acute coronary syndromes. It will also include patients qualify for percutaneous coronary interventions.
Micell plans to enroll the patients at around 10 clinical sites across the country.
The study has been designed to offer Japanese-specific data, which is supportive of DESSOLVE III, an all-comers clinical study that includes 1,400 patients randomized to MiStent or Xience at 20 sites in Europe.
DESSOLVE III completed enrollment in the last year. The company plans to file a pre-market approval application for Japanese approval following the completion of DESSOLVE J trial.
Saito said: "This study is a historic one for Japan. It will provide us with valuable insights into the potential benefits of MiStent's unique pharmacokinetic profile, with a rapidly absorbing polymer and extended elution of crystalline sirolimus."
Micell chairman and CEO Arthur Benvenuto said: "Cardiovascular disease poses a significant health risk in Japan and even with recent improvements in coronary artery disease treatment, additional advances in drug-eluting stents are still needed.”