Real Time Visualization of Clot under X-Ray Using "Clot-Paint", a Novel Iodinated

使用新型碘化物“Clot-Paint”在 X 射线下实时观察血块

基本信息

批准号：
7913705
负责人：
LUCJAN J J HRONOWSKI
金额：
$ 18.2万
依托单位：
BIOPSY SCIENCES, LLC
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-06-15 至 2011-12-14
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7913705
关键词：
Ablation Academia Acute Affinity Animal Model Animal Testing Animals Applications Grants Arizona Arteries Binding Binding Proteins Biopsy Blood Vessels Catheters Clinical Clinical Research Coagulation Process Contrast Media Coronary Thrombosis Cytolysis Detection Devices Doctor of Philosophy Excision Funding Goals Grant Hemorrhage Hour Human Image Imagery In Vitro Industry Injection of therapeutic agent Institution Intervention Intravenous Investigation Iodides Iodine Lasers Lead Measurement Measures Mechanics Medical Methods Monitor Oryctolagus cuniculus Paint Patients Penetration Peptides Peripheral Phase Physicians Polymer Chemistry Positioning Attribute Preparation Procedures Process Proteins Reperfusion Therapy Research Retrieval Risk Roentgen Rays Saline Science Side Site Small Business Innovation Research Grant Societies Solutions Speed Stroke Symptoms System Testing Thrombectomy Thrombosis Thrombotic Stroke Thrombus Time United States National Institutes of Health Universities X-Ray Computed Tomography abstracting amino group attenuation carboxyl group commercialization cost cost effective design experience femoral artery in vivo minimally invasive novel polypeptide public health relevance radiologist receptor receptor binding scale up time interval

项目摘要

DESCRIPTION (provided by applicant): Biopsy Sciences, LLC NIH SBIR Phase I Grant Application Real Time Visualization of Clot under X-Ray Using "Clot-Paint", a Novel Iodinated Protein Receptor Bound Molecule Project Summary/Abstract There are over 750,000 new cases of stroke in the U.S. each year. Of those suffering a major stroke, one-third will recover, one-third will die and one-third will be permanently impaired. The costs to society to treat stroke patients exceed $58 billion dollars a year in the U.S. Current acute embolic stroke treatment options include intravenous TPA administered within 3 hours after symptoms appear, intra-arterial TPA within 6 hours after the stroke onset and mechanical thrombectomy using the FDA cleared MERCI L5 retrieval system up to 6 hours and possibly longer after symptoms appear. Other clot retrieval/ablation devices (AngioJet, Latis laser device, EPAR laser, Penumbra system, Neuoronet snare) are under investigation but are not commercially available. Clot removal is the ideal treatment because of the speed of reperfusion and the lower risk of bleeding. We believe that ability to see the clot in real time during the intervention will help to shorten the time to clot removal and expand the number of physicians willing to participate in treating embolic strokes. Lysis alone can take up to 3 hours to dissolve the clot where clot removal can be performed in less than 30 minutes. Our long term objective is to introduce a novel contrast agent, "Clot-Paint" that is injected onto the clot through a catheter placed into the occluded artery. Clot-Paint adheres tightly to the intra-arterial thrombus via protein receptor sites while at the same time containing sufficient iodine molecules rendering the clot opaque to the x-ray beam and visible under fluoroscopic imaging for an extended period of time. This new molecule is composed of a clot binding protein and iodinated molecules. This novel contrast agent will allow the neurointerventional radiologist or cardiologist to visualize the clot with real time fluoroscopic imaging, thus allowing for accurate device positioning into the clot and to confirm successful clot capture into the device before removal. In addition, any clot fragments that migrate downstream could be readily identified and removed. Discussions with doctors who currently perform stroke intervention about this new contrast agent have confirmed the high potential clinical utility of such a novel contrast agent. PUBLIC HEALTH RELEVANCE: Biopsy Sciences, LLC NIH SBIR Phase I Grant Application Real Time Visualization of Clot under X-Ray Using "Clot-Paint", a Novel Iodinated Protein Receptor Bound Molecule Project Narrative There are over 750,000 new cases of stroke in the U.S. each year [1-3]. Of those suffering a major stroke, one-third will recover, one-third will die and one-third will be permanently impaired. Of the 750,000 strokes about half are caused by an embolic clot amenable to intervention [4, 5]. Other applications for this novel affinity contrast agent in vascular territory procedures include acute coronary thrombosis (84,000 patients/year/U.S.), peripheral arterial thrombosis (72,000 patients), DVT (75,000 patients) and PE (38,000) [6]. All of these patients will benefit from this molecule. One other side benefit of this molecule will be elimination or significant reduction of continuous large volume contrast injection for easier visualization of the clot during these interventional procedures.

描述（由申请人提供）：活检科学，LLC NIH SBIR I期授予应用程序在X射线下使用“ Clot-Paint”在X射线下实时可视化，这是一种新型的碘化蛋白受体结合的分子项目摘要/摘要，每年有超过750,000个新的中风新病例。在遭受重大中风的人中，三分之一将康复，三分之一将死去，三分之一将被永久损害。在美国，社会治疗中风患者每年超过580亿美元的费用超过580亿美元，包括症状出现后3小时内进行的静脉内TPA，动脉内TPA在中风开始后的6小时内，使用Merci L5 Extrieval System在6小时后进行了机械血栓切除术，最多可能会在6小时后出现。正在研究其他凝块检索/消融设备（AngioJet，Latis Laser设备，EPAR激光器，Penumbra System，Neuoronet Snare）正在研究中，但尚未商业上可用。由于再灌注速度和出血风险较低，凝块清除是理想的治疗方法。我们认为，在干预过程中实时看到凝块的能力将有助于缩短凝块清除和扩大愿意参与栓塞中风的医生的数量。仅裂解可能需要长达3个小时才能溶解可以在不到30分钟内进行凝块去除的凝块。我们的长期目标是引入一种新颖的对比剂“凝块绘制”，该对比剂通过放置在阻塞动脉中的导管注入凝块。通过蛋白质受体位点，凝块斑点紧紧地粘附到动脉内血栓上，同时含有足够的碘分子，使凝块不透明到X射线束并在荧光镜成像下可见以进行长时间。该新分子由凝块结合蛋白和碘化分子组成。这种新颖的对比剂将允许神经介入放射科医生或心脏病专家通过实时荧光影像成像可视化凝块，从而可以将其精确定位到凝块中，并在拆卸之前确认成功的凝块捕获到设备中。另外，任何迁移到下游的凝块片段都可以很容易地识别并去除。与目前对这种新对比剂进行中风干预的医生的讨论证实了这种新颖的对比剂的高潜在临床实用性。公共卫生相关性：活检科学，LLC NIH SBIR I期授予应用程序在X射线下使用“ Clot-Paint”在X射线下实时可视化，这是一种新型的碘化蛋白受体结合的分子项目叙事，每年在美国有超过750,000个新的中风病例[1-3]。在遭受重大中风的人中，三分之一将康复，三分之一将死去，三分之一将被永久损害。在750,000杆中，大约一半是由可被干预的栓塞凝块引起的[4，5]。这种新型亲和力对比剂在血管区域程序中的其他应用包括急性冠状动脉血栓形成（84,000名患者/年/美国），周围动脉血栓形成（72,000名患者），DVT（75,000名患者）和PE（38,000例）[6]。所有这些患者将从该分子中受益。该分子的另一个侧面益处将是消除或显着减少连续的大体积对比度注入，以便在这些介入过程中更容易地可视化凝块。