‘Stent versus stent＇ studies are a kind of randomized trials which are designed to show the superiority of the new stent designs compared with the previously approved ones. These studies are usually used by regulato...‘Stent versus stent＇ studies are a kind of randomized trials which are designed to show the superiority of the new stent designs compared with the previously approved ones. These studies are usually used by regulatory agencies, such as the U.S. Food and Drug Administration （FDA）, to give an approval to new stent designs. The problem with these clinical trials is their high cost and difficulty. In this paper, a numerical alternative for ＇stent versus stent＇ complicated clinical studies is presented. A finite element model is developed to investigate the influence of stent design on the outcome after coronary stent placement. Two commercially available stents （the NIR and Multi-Link stents） are modeled and their behavior during the deployment is compared in terms of stress distribution, radial gain, outer diameter changes and foreshortening. Moreover, the effect of stent design on the restenosis rate is investigated by comparing the stress distribution within the arteries. An analysis of the arterial wall stresses in the stented arteries indicates that the Multi-Link stent design causes lower stress to an atherosclerotic vessel with a localized stenotic lesion compared to the slotted tube NIR design. The findings correlate with the observed clinical restenosis rates, which have reported higher restenosis rates in the NIR compared with the Multi- Link stent design.展开更多
文摘‘Stent versus stent＇ studies are a kind of randomized trials which are designed to show the superiority of the new stent designs compared with the previously approved ones. These studies are usually used by regulatory agencies, such as the U.S. Food and Drug Administration （FDA）, to give an approval to new stent designs. The problem with these clinical trials is their high cost and difficulty. In this paper, a numerical alternative for ＇stent versus stent＇ complicated clinical studies is presented. A finite element model is developed to investigate the influence of stent design on the outcome after coronary stent placement. Two commercially available stents （the NIR and Multi-Link stents） are modeled and their behavior during the deployment is compared in terms of stress distribution, radial gain, outer diameter changes and foreshortening. Moreover, the effect of stent design on the restenosis rate is investigated by comparing the stress distribution within the arteries. An analysis of the arterial wall stresses in the stented arteries indicates that the Multi-Link stent design causes lower stress to an atherosclerotic vessel with a localized stenotic lesion compared to the slotted tube NIR design. The findings correlate with the observed clinical restenosis rates, which have reported higher restenosis rates in the NIR compared with the Multi- Link stent design.
