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

诊断性多模态血管内成像系统的临床评估和开发

基本信息

批准号：
8976336
负责人：
Tirunelveli Ramalingam
金额：
$ 35.04万
依托单位：
OCT MEDICAL IMAGING, INC.
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-09-01 至 2016-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8976336
关键词：
Address Affect Angiography Area Arterial Fatty Streak Arteries Back Biopsy Blood Vessels Boston Cadaver Caliber California Cardiovascular Diseases Catheters Clinical Clinical Research Clinical Trials Computer software Contrast Media Coronary Coupling Data Decision Making Detection Development Diagnosis Diagnostic Dimensions Disease Outcome Documentation Early Diagnosis Elements Ensure Exposure to FDA approved Family suidae Funding Heart Heart Diseases Histopathology Hospital Costs Hospitals Human Hybrids Image Imagery Imaging Techniques Institution Laboratories Lead Length Letters Licensing Marketing Measurement Measures Medical Medical Device Medical Imaging Modality Modeling Multi-Institutional Clinical Trial Multimodal Imaging Optical Coherence Tomography Outcome Patients Pennsylvania Phase Procedures Research Personnel Resolution Rotation Safety Saint Jude Children&apos s Research Hospital Sales Sampling Sensitivity and Specificity Site Specialist Speed Stenosis Stents System Systems Development Technology Testing Thrombus Time Tissues Torque Translations Ultrasonography Universities Work abstracting base biomaterial compatibility cost cost effective follow-up imaging system implantation improved medical schools millimeter miniaturize mortality novel outcome forecast performance tests prevent prospective public health relevance research clinical testing safety testing sensor stent thrombosis success time use ultra high resolution volcano

项目摘要

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

描述（由申请人提供）：认识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) 提议开发一种临床多模态血管内成像系统，包括超高分辨率光学相干断层扫描 (OCT) ）和 IVUS。这种组合的多模态血管成像系统将实现血管动脉的横截面可视化，其分辨率和深度是单独使用任何这些技术所无法实现的。系统允许使用单根一次性导丝，从而降低医院和患者的成本，并通过早期检测改善预后，我们相信这些技术将提供 1) 识别易损斑块所需的关键 3D 和横截面细节以及功能信息 2)。支架尺寸确定所需的血管内向外视图 3) 动脉支架支柱错位的程度 4) 支架后血栓形成的程度在多机构的努力下，我们计划创建此视图。多模态探头和必要的第一阶段的硬件，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 批准和营销