? The research outlined in this proposal is based on the observation that stent failure is due, in part, to acute thrombus accumulation combined with chronic hemodynamic and solid mechanical stress created by these devices within the host vessel. The proposed SBIR research program would test a working hypothesis in order to elucidate the relationship between acute thrombus accumulation and remodeling of the vessel. The hypothesis is that compliance mismatched stents create adverse stresses within the host vessel that promote tissue proliferation, and that this stress can be minimized with specific design improvements, specifically by matching or grading the mechanical compliance between the stent metal and the host tissue. This hypothesis would be tested during Phase I and during Phase II. ? ? The specific aims of the total SBIR program research are: ? ? 1. To analyze the fluid and solid mechanical stress created by compliance mismatched and compliance matched stents using experimental and computational methods in realistic arterial models. ? ? 2. To design and manufacture a structurally optimized compliance-matched coated stent based on this analysis. ? ? 3. To evaluate the in vivo performance of the optimized compliance-matched stent design in a swine model(presently funded by AHA). ? ? Specifically, NanoSonic would work with the Wake Forest University Medical Center to design, fabricate and evaluate stents coated with compliance-matched and compliance-graded mechanical coatings formed using molecular level layer-by-layer nanoassembly synthesis processes. These patented nanotechnology-based processes would allow the spatial grading of mechanical and other properties at the molecular level, specifically as required by our working hypothesis, to mitigate turbulent flow-induced restenosis. ? ?
