†These authors contributed equally.
Academic Editor: Carlo Briguori
Background: Covered stents are effective in treating coronary artery
perforation (CAP), however, the high rate of immediate device deployment failure
and in-stent restenosis have limited the application of the currently covered
stents. Methods: We designed a covered stent system consisting of a
single layer of drug-eluting stent and a layer of polytetrafluoroethylene (PTFE)
membrane wrapped at the outer layer of the stent. The immediate sealing effect of
our novel covered stent was observed by using an Ellis type III CAP model. The
device’s success was defined as its ability to seal the perforation, assessed by
visual estimation and final thrombolysis in myocardial infarction (TIMI) 3 flow.
The antiproliferative effect was evaluated in 12 swine, which were randomly
assigned to treatment (sirolimus-eluting covered stents) and control (bare metal
covered stents) groups. Coronary angiography and optical coherence tomography
(OCT) were performed at index procedure, 1- and 6-month after stent implantation.
All swine were sacrificed for histopathological analyses at 6-month.
Results: The device success rate was 100%. All swine were alive at
6-month follow-up. At 1-month, the treatment group had a larger minimal luminal
diameter (MLD) (1.89