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5 Developing a novel stent concept in the management of bifurcation disease
  1. AS Banning1,2,
  2. V Garitey2,
  3. K Mouniemne2,
  4. AH Gershlick3
  1. 1Glenfield Hospital, University Hospitals of Leicester NHS Trust
  2. 2ProtomedLabs, Marseille
  3. 3Glenfield Hospital, Leicester

Abstract

Introductions Provisional stenting is the accepted treatment for bifurcation disease, but techniques and stents for 1:1:1 disease can give sub-optimal results. We have developed a novel stent designed to be balloon modified in-situ to any bifurcation angle with no ingression of stent material into the main or side-branch lumen.

Methods Following design discussions, and extensive Finite Element Analysis studies with our non-commercial Industry partner two prototype (ST04 and ST05) were laser cut from cobalt chromium. In-vitro testing included detailed quantitative Micro-CT and video evaluation in silicone bifurcation models of 2 shapes (λ, Y) and 3 angles (45o, 60o,75o), n = 36. Prototypes were assessed for crush resistance.

Results Both prototypes showed successful longitudinally shortening (Figure 1). Mean distance from stent strut to vessel wall  was 0.11+/-0.04mm (ST04), 0.09+/-0.02mm (ST05) in λ-60o indicating excellent apposition, with no protrusion into either lumen. Crush resistance in the malleable part was lower than the standard section (eg: ST04 malleable end = 0.13+/-0.01N/mm; regular part=0.32+/-0.01N/mm p < 0.001).

Conclusions The results show proof-of-concept that a stent with a malleable end can be conformed to the side branch ostium with good apposition. This may translate into better outcomes for two-stent strategies in true bifurcation lesions.

Abstract 5 Figure 1

Fly-through 3D reconstruction image viewing carina from the main branch (Y-45 angle, sample ST04 A9); there is complete coverage of the carina with no evidence of stent protrusion into the side branch lumen (*) or main branch lumen (+)

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