Abstract

Abstract The main task of any vascular stent is the mechanical support of the re-opened vessel. This support function may be quantified by the compressive properties of the stent in radial outer loading conditions. Different test methods are standardized and are accepted to provide relevant data. Six commercially available self-expanding stents were investigated with regard to their forcedeformation behavior during radial as well as elliptical deformation. The measured radial resistive force and crush resistance were not qualitatively congruent for all stents. As a conclusion both test methods should be considered when describing the compressive properties of self-expanding stents.

Highlights

  • Lumen reduction of the femoropopliteal artery (FPA) due to arteriosclerosis is one cause for peripheral artery disease [1]

  • The Complete SE showed a 27% higher crush resistance (CR) and the Astron Pulsar a 63% lower CR

  • The non-congruent results of the CR and radial resistive force (RRF) of the tested self-expanding stents are based on the different loading mechanisms of the test methods itself [2, 8]

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Summary

Introduction

Lumen reduction of the femoropopliteal artery (FPA) due to arteriosclerosis is one cause for peripheral artery disease [1]. Due to severe mechanical deformations in the FPA during limb movement the implanted stents have to resist high mechanical loading caused by axial tension/compression, bending, torsion as well as radial compression [3]. The radial compression properties of the stent in combination with the chosen stent-to-vessel diameter ratio influence the interaction between stent and arterial wall, leading to a potential risk of arterial wall injury [2]. The impact of a high versus low radial force on neointimal hyperplasia in humans is not entirely clear, but is currently investigated within the BIOFLEX-COF trial [4]. Test methods to quantify the compressive properties of stents are standardized by international standards such as ISO 25539-2:2012 and ASTM F3067-14 [5, 6]. During stent design assessment the manufacturer has to evaluate the force that the stent can resist during deformation with parallel plates [5] as well as during radial deformation [5, 6]

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