Simplified Transfemoral Carotid Angioplasty and Stenting Under FlowReversal Using a Novel Combination Access Sheath/Balloon System

使用新型组合通路鞘/球囊系统在血流逆转下简化经股颈动脉血管成形术和支架置入术

• 批准号: 10081007
• 负责人: DAVID F KALLMES
• 金额: $ 39.81万
• 依托单位: MARBLEHEAD MEDICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-20 至 2021-04-27
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10081007
• 关键词: Angioplasty; Animal Testing; Balloon Occlusion; Blood; Blood flow; Brain; Caliber; Carotid Arteries; Carotid Artery Diseases; Carotid Endarterectomy; Carotid Stenosis; Carotid stent; Catheters; Clinical; Coagulation Process; Common carotid artery; Communities; Complex; Complication; Contralateral; Development; Device or Instrument Development; Devices; Dilator; Distal; Embolism; Engineering; External carotid artery structure; Family suidae; Freezing; Goals; In Vitro; Internal carotid artery structure; Investigation; Ipsilateral; Length; Length of Stay; Measures; Methods; Modeling; Operative Surgical Procedures; Outcome; Patient Care; Patients; Phase; Preclinical Testing; Procedures; Resistance; Risk; Safety; Savings; Silk; Small Business Technology Transfer Research; Speed; Stents; Sterility; System; Testing; Time; Toxicology; Validation; Withdrawal; artery occlusion; base; design; design and construction; embolic stroke; femoral artery; good laboratory practice; hemodynamics; high risk; improved; improved outcome; in vitro testing; in vivo; in vivo evaluation; innovation; interest; minimally invasive; novel; operation; programs; standard care; standard of care; success; surgical risk; tool; vertebral artery

PROJECT SUMMARY Carotid Artery Stenting (CAS) using embolic protection represents the current standard of care for patients with carotid artery stenosis considered at high risk for carotid endarterectomy. Distal filter devices are the most widely used protection devices, but these must be navigated through plaque prior to deployment, presenting a significant embolic risk. Strong evidence indicates proximal protection devices, especially using flow reversal, improve outcomes compared to distal protection devices. Currently in the US, there exists no minimally invasive, transfemoral system for flow reversal CAS; the only currently marketed flow reversal system (Silk Road) requires a surgical cutdown of the common carotid artery. Silk Road has the advantage of short, large bore catheter systems that maximize flow reversal. Previous transfemoral flow reversal products (Parodi, Gore), since removed from the market, required complex, dual balloon systems that prolonged procedures and added risk. In this proposal, we will develop and validate the Femoral Flow Reversal Access for Carotid Artery Stenting (FFRACAS) device, to provide the endovascular therapy community with a novel tool that does not require invasive surgery and will speed carotid artery stenting while facilitating a flow reversal. The central innovation of our device is aimed at minimizing the system’s outer diameter and maximizing its inner diameter balloon occlusion device that functions both as a long arterial introducer sheath and an occlusion balloon, with a relatively small OD and profoundly increased ID. As a result, the flow reversal capability of our system, even without need for a dual balloon approach, is as good or better than Silk Road. These key features in our proposed device will facilitate a better, safer and faster alternative to CAS. Our specific aims are 1) to develop and perform in vitro pilot testing of our FFRACAS device, and 2) to perform iterative in vivo testing and validation of the FFRACAS device in swine carotid artery model. Our primary objective is for the FFRACAS device to 1) provide ease of percutaneous placement, 2) achieve atraumatic cessation of antegrade flow, and 3) achieve in vivo rates of reversed flow equal to or greater than that of the Silk Road device (the best standard for treatment via reverse flow) at each stage of the CAS procedure. Completion of these goals in Phase 1 will pave the way toward design validation and development of an Investigational New Device trial in Phase 2. We anticipate that the use of our device will create better, minimally-invasive curative solutions to CAS.

项目摘要 颈动脉支架（CAS）使用栓塞保护表示当前的护理标准 颈动脉狭窄的患者认为颈动脉内膜切除术风险很高。远端过滤器设备是 使用最广泛的保护设备，但是这些设备必须在部署前通过牌匾导航， 出现重大栓塞风险。有力的证据表明近端保护设备，尤其是使用 与不同的保护设备相比，流动逆转，改善结果。目前在美国，没有 流动逆转CAS的最小侵入性，经济系统；目前唯一销售的流动逆转 系统（丝绸之路）需要对普通颈动脉进行手术切割。丝绸之路有优势 短而大的孔导管系统，可最大程度地逆转流动。以前的转换逆转产品 （Parodi，Gore）自从从市场上删除，需要延长的复杂的双气球系统 程序并增加了风险。 在此提案中，我们将开发和验证颈动脉的股骨流逆转通道 支架（FFRACAS）设备，为血管内治疗社区提供一种新的工具 需要进行侵入性手术，并在支撑流动逆转的同时加快颈动脉支架。中央 我们设备的创新旨在最大程度地减少系统的外径并最大化其内径 气球闭塞装置，既可以用作长的动脉引进器鞘和遮挡气球， 相对较小的OD和ID大大增加。结果，我们系统的流动逆转能力，甚至 不需要双气球方法，比丝绸之路一样好或更好。这些关键特征在我们 提议的设备将促进CAS的更好，更安全，更快的替代方案。 我们的具体目的是1）开发和执行FFRACAS设备的体外试验测试，以及2） 在猪颈动脉模型中对FFRACAS装置进行体内测试和验证。我们的 主要目标是FFRACAS设备1）提供易于经皮放置，2）实现 暂停前的流动流，3）实现相反流量的体内速率等于或大于或大于 CAS的每个阶段的丝绸之路设备（通过反向流的最佳标准） 程序。在第1阶段完成这些目标将为设计验证和开发铺平道路 在第2阶段的研究性新设备试验中，我们预计我们的设备的使用将会更好， CAS的最小侵入性治疗溶液。