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

 描述（由申请人提供）：了解到没有一种成像技术可以单独满足所有血管诊断的需求，OCT医学成像公司（OCTMI）提出开发一种包含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。这种组合式多模式血管成像系统将允许血管动脉的横截面可视化，其分辨率和深度前所未有，单独使用这些技术是不可能的。在单个系统中的这种多模式成像策略允许使用单个一次性导丝，从而降低医院、患者的成本并通过早期检测改善预后。我们相信这些技术将共同提供1）识别易损斑块所需的关键3D和横截面细节和功能信息2）支架尺寸测量所需的血管内-外视图3）动脉中支架支柱贴壁不良的程度4）支架后血栓形成的程度。在多机构的努力下，我们计划创建这种多模式探测器， 第一阶段是硬件，第二阶段是广泛的临床试验，第三阶段是寻求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