一Stent Design

The biodegradable coating (PLGA polymer combined with sirolimus crystals) was realized based on supercritical fluid technology, which gave birth to the Mistent® coronary drug-eluting stent. It has two distinctive features: "Quick Healing" and "Long-lasting Drug Efficacy". The biodegradable polymer enables rapid endothelialization and reduces chronic inflammation and the occurrence of stent thrombosis; the controlled and slow-release of sirolimus drug crystals for up to 9 months reduces late lumen loss of the stent.

二Clinical Study

Mistent® coronary drug-eluting stent system has undergone numerous clinical studies worldwide, involving over 2,000 patients.

DESSOLVE I

The DESSOLVE I study is a multicenter, single-arm clinical trial involving 30 patients. It assesses the device's performance through coronary angiography, optical coherence tomography (OCT), and intravascular ultrasound (IVUS) and evaluates its safety through major adverse cardiac events (MACE) after MiStent SES implantation.

At different time points, late lumen loss (LLL) was measured by angiography. The results indicated that during the period of 6 months and 18 months, there was no progression of late lumen loss after implantation in these patients (0.9 ± 0.11 and 0.09 ± 0.15 respectively).

In the OCT analysis of results of the 4th, 6th and 8th months, thin and uniform vascular endothelial coverage was observed at the stent strut sites. The stent strut coverage occurred earlier and had a high coverage rate (93% at the 4th month, 97% at the 6th month, 96% at the 8th month, and 100% at the 18th month).

DESSOLVE II

DESSOLVE II is a randomized clinical trial that compared MiStent SES and Endeavor Sprint zotarolimus-eluting stents. A total of 184 subjects from 26 centers were randomly assigned in a 2:1 ratio to receive MiStent SES or Endeavor ZES implantation.

The results showed that MiStent SES was superior to Endeavor ZES, with a significant reduction in late lumen loss (0.27 ± 0.46 and 0.58 ± 0.41, p < 0.001).

In the subgroup analysis, patients underwent OCT and endothelial function analysis at the 9th month. The OCT analysis indicated that the proportion of endothelial coverage within the stent struts was high (99.7%), and there were no signs of poor stent strut adherence (0%). The endothelial function test showed that endothelial function was preserved. These results indicated that the vascular healing was good and the endothelial function returned to normal.

At 5 years after the operation, the incidences of major adverse cardiovascular events (MACE) in the MiStent group and the Endeavor control group were 15.1% and 22.0% respectively, and the incidence of target lesion revascularization (TLR) was 3.4% in both groups.

DESSOLVE III

DESSOLVE III study is a prospective, randomized, 1:1 controlled, single-blind, multicenter study that compared the clinical outcomes of MiStent SES and XIENCE in the "real-world all-comer" patient population at the 12th month.

This study demonstrated that MiStent SES was non-inferior to Xience, and that the TLF, TLR, ST and TVMI of MiStent SES showed a decreasing trend.