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).
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