Application of PPODA-QT for embolization of aneurysms

PPODA-QT在动脉瘤栓塞治疗中的应用

• 批准号: 9254668
• 负责人: Tim Becker
• 金额: $ 22.01万
• 依托单位: ANEUVAS TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-02-01 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9254668
• 关键词: Acute; Address; Affect; American; Aneurysm; Animals; Biocompatible Materials; Biomedical Engineering; Blood Pressure; Blood flow; Brain; Canis familiaris; Catheters; Cerebral Aneurysm; Clinical; Clinical assessments; Collaborations; Complement; Contrast Media; Data; Devices; Elastases; Embolism; Environment; Exhibits; FDA approved; Family suidae; Fatigue; Gel; Goals; Hemorrhage; Human; Hybrids; Image; Imagery; In Vitro; Injection of therapeutic agent; Investigation; Lesion; Liquid substance; Materials Testing; Mechanics; Medical; Medical Device; Metals; Modeling; Morbidity - disease rate; Operative Surgical Procedures; Optics; Oryctolagus cuniculus; Outcome; Particulate; Patients; Phase; Physicians; Polymers; Powder dose form; Preparation; Procedures; Process; Publishing; Research; Resistance; Risk; Rupture; Ruptured Aneurysm; Safety; Sampling; Side; Small Business Innovation Research Grant; Solid; Stress; Stroke; System; Tantalum; Techniques; Technology; Testing; Therapeutic Embolization; United States; Validation; Work; base; biomaterial compatibility; density; design; experience; field study; healing; in vitro Model; in vivo; innovation; medical attention; meetings; metallicity; migration; minimally invasive; mortality; neurosurgery; neurovascular; novel; pre-clinical; pressure; response; shear stress; therapeutic effectiveness; validation studies; weapons

A cerebral aneurysm is an abnormal enlargement or pouch that forms from a weakened vessel segment in the brain. Often going unnoticed and untreated, an aneurysm can cause a sudden and catastrophic hemorrhage or stroke. Approximately 15 % of patients die from an aneurysm rupture even before receiving medical attention and 25 % of patients die despite medical treatment. Patients that survive typically suffer from various levels of morbidity. Thus, only one in four patients who suffer a ruptured aneurysm will fully recover. It is estimated that between 3 million and 6 million Americans have cerebral aneurysms, and approximately 20,000 people in the United States suffer hemorrhage each year. While there have been notable recent advances in providing minimally invasive access to aneurysms using advanced micro-catheter systems, there is a paucity of equally high performing embolization materials that can be delivered through these catheters to effectively treat clinically challenging lesions. The purpose of this venture is to provide an innovative biomaterial (PPODA-QT) for the endovascular treatment of aneurysms in order to significantly increase therapeutic effectiveness while minimizing surgical risks. This Phase I proposal will develop techniques to test PPODA-QT’s visualization during injection and its mechanical stability and resistance to particulation and downstream migration. The primary objective of this project is to characterize and optimize PPODA-QT for submission to the FDA for Investigational Device Exemption (IDE) approval. Preliminary studies have shown that PPODA-QT can be formulated and delivered to effectively occlude long-term animal aneurysm models while also promoting a positive bioactive healing response that may permanently stablize the aneurysm. Our goal is to begin validation of these preliminary PPODA-QT results by following the comprehensive procedures laid-out by the FDA to promote safety and efficacy from new liquid embolic devices. The outcomes of the proposed investigations in this SBIR Phase I application, combined with our previously published research results, will help jump-start the pre- clinical assessment of PPODA-QT for endovascular embolization of aneurysms.

脑动脉瘤是一种异常增大或囊状物，形成于 脑部的血管部分被削弱。经常不被注意和治疗，一个 动脉瘤可导致突然的灾难性出血或中风。大致 15%的患者甚至在接受治疗之前就死于动脉瘤破裂 尽管接受了治疗，但仍有25%的患者死亡。存活下来的患者通常会遭受 来自不同程度的发病率。因此，只有四分之一的患者患有脑膜破裂 动脉瘤会完全恢复的。据估计，在300万到600万之间 美国人患有脑动脉瘤，美国约有2万人 各州每年都会遭受大出血。 虽然最近在提供微创技术方面取得了显著进展 使用先进的微导管系统进入动脉瘤，目前还缺乏 同样高性能的栓塞剂可以通过这些 有效地治疗临床上具有挑战性的病变的导管。这个项目的目的是 提供一种创新的生物材料(PPODA-QT)用于血管内治疗 为了显著提高治疗效果，同时最大限度地减少 手术风险。 这个第一阶段的提案将开发测试PPODA-QT可视化的技术 在注射过程中，其机械稳定性和抗颗粒性和 向下游迁移。这个项目的主要目标是描述和描述 优化PPODA-Qt以提交给FDA进行调查设备豁免 (IDE)批准。 初步研究表明，PPODA-QT可以配制并交付给 有效阻断长期动物动脉瘤模型的同时也促进了积极的 可能永久稳定动脉瘤的生物活性愈合反应。我们的目标是 开始验证这些初步的PPODA-QT结果，遵循全面的 FDA为提高新型液体栓塞剂的安全性和有效性而制定的程序 设备。在本SBIR第一阶段申请中拟议的调查结果， 结合我们之前发表的研究成果，将有助于启动预 PPODA-QT血管内栓塞术治疗动脉瘤的临床评价

项目成果

Application of a rabbit-elastase aneurysm model for preliminary histology assessment of the PPODA-QT liquid embolic.

• DOI: 10.25259/sni_163_2021
• 发表时间: 2021
• 期刊: Surgical neurology international
• 作者: Huckleberry A;Merritt W;Cotter T;Settanni C;Preul MC;Ducruet AF;Becker TA
• 通讯作者: Becker TA

Quantifying the mechanical and histological properties of thrombus analog made from human blood for the creation of synthetic thrombus for thrombectomy device testing.

• DOI: 10.1136/neurintsurg-2017-013675
• 发表时间: 2018-12
• 期刊: Journal of neurointerventional surgery
• 影响因子: 4.8

Large, Wide-Neck, Side-Wall Aneurysm Treatment in Canines Using NeuroCURE: A Novel Liquid Embolic.

使用 NeuroCURE：一种新型液体栓塞治疗犬科动物的大型宽颈侧壁动脉瘤。

• DOI: 10.1161/svin.123.000857
• 发表时间: 2023
• 期刊: Stroke (Hoboken, N.J.)
• 作者: Merritt,WilliamC;Norris,Nicholas;Robertson,Sophia;Preul,MarkC;Ducruet,AndrewF;Becker,TimothyA
• 通讯作者: Becker,TimothyA