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的增强或袋 大脑中的血管段削弱了。经常不被注意和未经治疗，这是 动脉瘤会引起突然而灾难性的出血或中风。大约 15％的患者甚至在接受医疗护理之前就死于动脉瘤破裂 和25％的患者死亡目的地医疗。生存的患者通常会受苦 来自各种发病率。那，只有四分之一的患者破裂 动脉瘤将完全恢复。据估计，300万到600万 美国人患有脑动脉瘤，联合有大约20,000人 各州每年遭受出血。 虽然最近在提供最小的侵入性方面取得了显着进步 使用高级微型导管系统访问动脉瘤，很少 同样高的栓塞材料，可以通过这些材料传递 导管有效治疗临床上具有挑战性的病变。这项合资的目的是 提供创新的生物材料（PPODA-QT），以进行血管内治疗 动脉瘤以显着提高治疗效果，同时最大程度地减少 手术风险。 该阶段I建议将开发用于测试PPODA-QT可视化的技术 在注射及其机械稳定性和对特殊性的抵抗力和 下游迁移。该项目的主要目的是表征和 优化PPODA-QT提交给FDA进行调查设备豁免 （IDE）批准。 初步研究表明，PPODA-QT可以制定并交付到 有效地遮住长期动物动脉瘤模型，同时也促进阳性 生物活性愈合反应可能会永久稳定动脉瘤。我们的目标是 通过遵循综合 FDA放置的程序以促进新液体栓塞的安全性和效率 设备。在此SBIR I期应用程序中提议的调查的结果， 结合我们先前发表的研究结果，将有助于启动前 PPODA-QT的临床评估用于动脉瘤的血管内栓塞。

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