Transvenous Optoacoustic-Ultrasound Guided Cold Laser Wire for Crossing Coronary Chronic Total Occlusion

经静脉光声超声引导冷激光线穿越冠状动脉慢性完全闭塞

• 批准号: 10612422
• 负责人: MARC David FELDMAN
• 金额: $ 63.98万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-01 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10612422
• 关键词: Acute; Address; Adipose tissue; Affect; American; Angiography; Animal Model; Anterior Descending Coronary Artery; Arterial Fatty Streak; Arteries; Atherosclerosis; Blood flow; Bypass; California; Cardiac; Cardiac Surgery procedures; Cardiac Tamponade; Cardiology; Cardiovascular Diseases; Catheters; Cessation of life; Chest Pain; Chronic; Clinic; Complex; Complication; Coronary; Coronary Artery Bypass; Coronary artery; Development; Devices; Diameter; Discipline; Disease; Dissection; Elderly; Endothelial Cells; Environment; Event; Failure; Family suidae; Fatigue; Fiber; Fiber Optics; Goals; Health; Heart Transplantation; Hour; Human; Image; Injury; Intervention; Lasers; Left; Left Ventricular Ejection Fraction; Length of Stay; Lesion; Light; Mechanics; Medical; Morbidity - disease rate; Myocardial Infarction; Operative Surgical Procedures; Optics; Organ Transplantation; Outcome; Participant; Patient-Focused Outcomes; Patients; Perforation; Peripheral; Procedures; Program Development; Recovery; Research; Shortness of Breath; Side; Stents; Structure of left gastric vein; Symptoms; System; Techniques; Testing; Therapeutic; Time; Treatment Protocols; Ultrasonography; Universities; Vascularization; Veins; Venous; calcification; cell injury; cost; design; image guided; imaging system; improved; in vivo; innovation; minimally invasive; mortality; novel; optical fiber; percutaneous coronary intervention; photoacoustic imaging; pressure; randomized, controlled study; real-time images; reduce symptoms; research and development; restenosis; safe patient; sound; stent thrombosis; ultrasound; Acute; Address; Adipose tissue; Affect; American; Angiography; Animal Model; Anterior Descending Coronary Artery; Arterial Fatty Streak; Arteries; Atherosclerosis; Blood flow; Bypass; California; Cardiac; Cardiac Surgery procedures; Cardiac Tamponade; Cardiology; Cardiovascular Diseases; Catheters; Cessation of life; Chest Pain; Chronic; Clinic; Complex; Complication; Coronary; Coronary Artery Bypass; Coronary artery; Development; Devices; Diameter; Discipline; Disease; Dissection; Elderly; Endothelial Cells; Environment; Event; Failure; Family suidae; Fatigue; Fiber; Fiber Optics; Goals; Health; Heart Transplantation; Hour; Human; Image; Injury; Intervention; Lasers; Left; Left Ventricular Ejection Fraction; Length of Stay; Lesion; Light; Mechanics; Medical; Morbidity - disease rate; Myocardial Infarction; Operative Surgical Procedures; Optics; Organ Transplantation; Outcome; Participant; Patient-Focused Outcomes; Patients; Perforation; Peripheral; Procedures; Program Development; Recovery; Research; Shortness of Breath; Side; Stents; Structure of left gastric vein; Symptoms; System; Techniques; Testing; Therapeutic; Time; Treatment Protocols; Ultrasonography; Universities; Vascularization; Veins; Venous; calcification; cell injury; cost; design; image guided; imaging system; improved; in vivo; innovation; minimally invasive; mortality; novel; optical fiber; percutaneous coronary intervention; photoacoustic imaging; pressure; randomized, controlled study; real-time images; reduce symptoms; research and development; restenosis; safe patient; sound; stent thrombosis; ultrasound

ABSTRACT Coronary chronic total occlusions (CTOs) are atherosclerotic plaques comprised of hard fibro-calcific material that restrict luminal cross-section by 100% resulting in complete stoppage of blood flow in the affected artery for at least three months. CTO symptoms include shortness of breath with chronic fatigue and chest pain. The three primary CTO treatment regimens are medical therapy (MT), coronary artery bypass graft (CABG) and percutaneous coronary interventions (PCI). MT can reduce symptoms such as chest pain but fail to address the underlying disease mechanisms. CABG does provide marked improvements in both patient morbidity and mortality, however, this open-heart surgical intervention is highly invasive, traumatic, expensive and has a limited lifetime. Because most CABG grafts utilize re-purposed veins, 50% become occluded within ten years after bypass surgery. PCI procedures are provided over a 24-hour hospital stay, have one-two days of recovery time and cost approximately one-fourth of CABG yet are currently administered to only 10% of CTO patients. In the most common PCI procedure, subintimal crossing, a mechanical wire is advanced past the CTO inside the vessel wall. Few interventionalists practice subintimal crossing because the procedure is difficult, risky and associated with higher MACE, restenosis, acute MI and death. Although many intravascular devices have been introduced to perform PCI true-lumen CTO crossing, all have failed in the coronary arteries. Failure of these previous devices is due to at least one of three causes: 1) large-diameter catheters that are too rigid with poor steerability; 2) non-specific injury to the vessel wall resulting from CTO cutting; and 3) absence of a navigational guidance system based on real-time imaging of the catheter tip relative to the arterial wall. An optoacoustic (OA) and ultrasound (US) image-guided cold laser wire (CLW) is proposed that provides controlled cutting that will allow any interventional cardiologist to provide patients safe and efficacious PCI true-lumen CTO crossing. Development of the transvenous OA/US image-guided CLW will be accomplished by completing three specific aims: Aim 1: Develop an Optoacoustic (OA)/Ultrasound (US) Transvenous Image-Guided Cold Laser Wire; Aim 2: Test CLW True-Lumen PCI CTO Crossing in ex vivo Human CABG Hearts; Aim 3: Test CLW True-Lumen PCI Crossing of Calcified CTOs in in vivo Animal Models. Successful completion of the proposed research and development program will introduce a true-lumen PCI CTO crossing procedure that when followed by stenting can establish a superior and new treatment paradigm for interventional cardiology and can impact other surgical disciplines.

抽象的 冠状动脉总闭塞（CTO）是动脉粥样硬化斑块，由硬纤维 - 钙含量材料组成 这将腔横截面限制为100％，导致受影响动脉的血流完全停止 至少三个月。 CTO症状包括呼吸急促和慢性疲劳和胸痛。这 三种主要的CTO治疗方案是医疗治疗（MT），冠状动脉搭桥移植物（CABG）和 经皮冠状动脉干预（PCI）。 MT可以减轻诸如胸痛等症状，但无法解决 潜在的疾病机制。 CABG确实在患者发病率和 然而，死亡率是这种心脏直觉的手术干预措施高度侵入性，创伤性，昂贵，并且有限 寿命。由于大多数CABG移植物都使用重新施加的静脉，因此50％在十年内被遮挡 心脏搭桥手术。 PCI手术是在24小时住院期间提供的，有一二天的恢复时间 目前仅对10％的CTO患者进行了大约四分之一CABG的费用。在 最常见的PCI程序，下部横梁，机械线是在血管内部的CTO上升空的 墙。很少有干预主义者练习亚紧张杂交，因为该程序困难，风险和相关性 具有更高的狼牙棒，再狭窄，急性MI和死亡。尽管已经引入了许多血管内装置 为了执行PCI真实的CTO交叉，所有这些都在冠状动脉中都失败了。这些以前的失败 设备至少是由于三个原因中的至少一个造成的：1）太刚性的大直径导管，可固定性差； 2）CTO​​切割引起的血管壁伤害； 3）缺乏导航指导 基于导管尖端的实时成像相对于动脉壁的系统。光声（OA）和 提出了超声（US）图像引导的冷激光线（CLW），提供可控的切割，将允许 任何介入的心脏病专家都可以为患者提供安全有效的PCI真实的CTO交叉。 通过完成三个特定的特定的特定于 目的：目标1：开发光声（OA）/超声（美国）透性图像引导的冷激光 金属丝; AIM 2：在体内人类Cabg心脏中测试clw true lumen pci cto crossing;目标3：测试clw 在体内动物模型中钙化CTO的真实lumen PCI穿越。成功完成 拟议的研究与开发计划将引入真正的lumen PCI CTO交叉程序 随后支架可以建立介入心脏病学的卓越和新的治疗范式 并可能影响其他手术学科。