Clinical evaluation and development of a diagnostic multi-modal intravascular imaging system

 描述(由申请人提供)：OCT医学成像公司(OCTMI)认识到，没有一种单一的成像技术可以单独满足所有血管诊断的需求，因此建议开发一种包括超高分辨率光学相干断层扫描(OCT)和IVUS的临床多模式血管内成像系统。这种组合的多模式血管成像系统将允许以前所未有的分辨率和深度对血管动脉进行横断面可视化，而仅使用这些技术是不可能的。这种单一系统中的多模式成像策略允许使用单一的一次性导丝，从而降低了医院和患者的成本，并通过早期发现改善了预后。我们相信，这些技术结合在一起将提供1)关键的3D和横断面细节-识别易损斑块所必需的功能信息2)支架尺寸确定所需的血管内侧向外视图3)支架支柱在动脉中错位的程度4)支架后血栓形成的程度。在一个多机构的努力中，我们计划创建这个多模式的调查和必要的 硬件在第一阶段，随后在第二阶段进行广泛的临床试验，然后在第三阶段寻求FDA批准和上市

 DESCRIPTION (provided by applicant): Understanding that not a single imaging technique can alone address needs of all vascular diagnosis, OCT medical imaging Inc. (OCTMI) propose to develop a clinical multimodal intravascular imaging system encompassing ultra-high resolution optical coherence tomography(OCT) and IVUS. This Combined multimodal vascular imaging system will permit cross-sectional visualization of vascular artery with unprecedented resolution and depth not possible with any of these technologies alone. This multi-modal imaging strategy in a single system permits use of a single disposable guide wire, thereby reducing cost to hospital, patients and improving prognosis by early detection. We believe these technologies together will provide 1) critical 3D and cross-sectional details & functional information necessary for identifying vulnerable plaques 2) inside-out view of vessel necessary for stent sizing 3) extent of mal-apposition of stent struts in artery 4) extent of post-stent thrombosis. In a multi-institutional effort, we plan to create this multi-modal probe and necessary hardware in Phase I, followed by extensive clinical trials in phase II before seeking FDA approval and marketing in Phase III