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 使用栓塞保护的颈动脉支架植入术（CAS）代表了目前的标准治疗， 颈动脉狭窄患者被认为是颈动脉内膜切除术的高风险。远端过滤器装置是 最广泛使用的保护装置，但这些装置在部署之前必须通过斑块导航， 存在显著的栓塞风险。强有力的证据表明近端保护装置，特别是使用 与远端保护装置相比，逆流改善了结局。目前在美国，没有 用于血流逆转CAS的微创经股动脉系统;目前唯一上市的血流逆转 系统（丝绸之路）需要手术切断颈总动脉。丝绸之路的优势在于 最大化流动反向的短、大口径导管系统。既往经股动脉血流逆转产品 （Parodi，戈尔），因为从市场上撤出，需要复杂的，双球囊系统，延长 程序和增加的风险。 在本提案中，我们将开发并确认颈动脉股动脉血流抑制入路 支架（FFRACAS）器械，为血管内治疗界提供一种新的工具， 需要侵入性手术，并且将加速颈动脉支架植入术，同时促进血流逆转。中央 我们设备的创新旨在最小化系统的外径并最大化其内径 球囊闭塞装置，既用作长动脉导引鞘又用作闭塞球囊， 一个相对较小的OD和大大增加的ID。因此，我们的系统的流动逆转能力，甚至 而不需要双气球的方法，是一样好或更好的丝绸之路。我们的这些关键功能 拟议的设备将有助于更好、更安全和更快地替代CAS。 我们的具体目标是：1）开发和执行FFRACAS器械的体外试验，2） 在猪颈动脉模型中对FFRACAS器械进行迭代体内测试和确认。我们 FFRACAS器械的主要目的是：1）提供经皮放置的便利性，2）实现 顺行流动的非创伤性停止，和3）实现等于或大于 在CAS的每个阶段，丝绸之路装置（通过反向流处理的最佳标准） procedure.在第1阶段完成这些目标将为设计验证和开发铺平道路 II期研究性新器械试验。我们预计，使用我们的设备将创造更好的， CAS的微创治疗解决方案。