Abstract
PURPOSE: The purpose of this study was to evaluate basic experimental data for the clinical application of a self-expandable stainless steel intravascular Hanaro spiral stent.
MATERIALS AND METHODS: For evaluation of thephysical properties of the Hanaro stent, hoop strength, radioopacity, longitudinal flexibility, and foreshortening were measured. Twelve intravascular Hanaro spiral stents were placed in the infrarenal abdominal aorta (n=6) and comon iliac artery (n=6) in six mongrel dogs. Angiography and light microscopic examination were performed after one, two and eight months of placement of the stents.
RESULTS: The stent had good radioopacity and was deployed with minimal foreshortening. Hoop strength of a 6mm-interval bend was found to be superior to that of 8mm- and 10mm-bend stent. On angiography the patency rate and thrombosis rate were 100% and 0% in the abdominal aorta and 50% and 50% in the common iliac artery, respectively. Minimal corrosion was seen in all stents, and they appearedto be biocompatible. The stent wires were covered with well-developed neointima which after one month had mostly fibroblast and collagen tissue; the thickness of the neointima increased gradually during a period of eightmonths. At the end of that period, collagen fibres in the neointima were denser and showed a more paralled configuration than at one month.
CONCLUSION: The Hanaro stent has good physical properties and also has a high patency rate, and good biocompatibilities. The stent may therefore be reliably and safely deployed in the humanvascular system.