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7 Pre-clinical studies in a novel side-branch stent
  1. Amerjeet S Banning1,2,
  2. Vincent Gariety3,
  3. Karim Mouniemne3,
  4. Justyna Janus4,
  5. Michael Kelly4,
  6. Julian P Gunn5,
  7. Anthony H Gershlick1,2
  1. 1Glenfield Hospital, University Hospitals of Leicester NHS Trust, Leicester, UK
  2. 2Department of Cardiovascular Sciences, University of Leicester, UK
  3. 3ProtomedLabs, Marseille, France, London, UK
  4. 4Department of Pre-Clinical Imaging, University of Leicester, UK
  5. 5Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, UK

Abstract

Background Bifurcation lesion stenting remains an area for translational research focus, since provisional stenting, while commonly used, may be inadequate in many cases and currently available ‘bifurcation’ stents are limited.

Methods We have developed a novel side branch stent with a modifiable end through controlled longitudinal shortening, allowing adaptation to any bifurcation angle.

Results Design optimisation and computational finite element analysis resulted in good virtual bifurcation apposition. Safety testing data informed laser-cutting of cobalt chromium prototypes with appropriate tensile stress characteristics, and deployed in silicone bifurcation model -λ and Y shapes at 60o, 45o angles, MicroCT showed only 2.8% mal-apposed struts; mean wall distance 0.03±0.02 mm. Mechanical testing showed low recoil (4.01%±1.31%) and foreshortening (2.15%±0.68%) and good radial strength (malleable end 0.21±0.01 N/mm, regular part=0.24±0.01 N/mm). The optimally performing prototype (Iteration7) was deployed in 20 porcine coronary bifurcations, with initial MicroCT indicating minimal stent protrusion into main/side branch lumen and complete bifurcation angle coverage (figure 1).

Conclusion 4 years of bench, in-vitro and in-vivo studies show proof-of-concept that an in-vivo modifiable stent can be used to stent coronary bifurcation side-branches. Work towards first-in-man studies is on-going.

Abstract 7 Figure 1

Prototype stent deployment in porcine LCx/OM bifurcation. A: angiogram showing side-branch stent (arrow). B: micro-CT image of stented LCx/OM bifurcation (blue arrow=side branch stent). C: fly-though image; side branch OM (*) and main-branch LCx lumen (+)

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