A new stent design for the treatment of true bifurcation lesions: H-side branch stents

Abstract

BACKGROUND: There has been much debate for the adequate treatment strategies for true bifurcation lesions. The purpose of this study is to introduce and test a novel stent design for the treatment of true bifurcation lesions.

METHODS: This side branch stent is composed of three parts: proximal, connecting, and distal parts. The distal part for the side branch vessel has a slope-side stent margin for circumferential coverage of the ostium and one radio-opaque marker for targeting the carina. The proximal part with two radio-opaque markers operates for safe stent delivery and useful guidance for a more precise placement of the distal part on the side branch ostium. Results of the in vitro test in the acrylic resin-made bifurcation phantom model were evaluated with microcomputer tomography. Animal experiments with this new stent platform were also performed in five pigs.

RESULTS: In vitro test and microcomputer tomography showed complete coverage of the side branch ostium circumferentially with stent struts, and the absence of stent struts in the main vessel above the side branch ostium level. This side branch stents were successfully deployed in all 5 pigs. The results of animal experiments were also similar to those of in vitro tests.

CONCLUSIONS: In vivo and vitro tests demonstrated the effective modality of this side branch stent for the treatment of true bifurcation lesions