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.

项目概要 使用栓塞保护的颈动脉支架置入术 (CAS) 代表了当前的护理标准 颈动脉狭窄的患者被认为是颈动脉内膜切除术的高风险患者。 使用最广泛的保护装置，但在部署之前必须通过斑块进行导航， 强有力的证据表明存在显着的栓塞风险，尤其是使用近端保护装置。 与远端保护装置相比，目前在美国还没有这种装置。 用于血流逆转的微创经股动脉系统 CAS；目前唯一上市的血流逆转系统； 系统（丝绸之路）需要手术切断颈总动脉，丝绸之路具有优势。 短、​​大口径导管系统，可最大限度地实现先前的经股动脉血流逆转产品。 （Parodi，Gore）自从退出市场以来，需要复杂的双气球系统，以延长 程序和增加的风险。 在本提案中，我们将开发并验证颈动脉股血流逆转通路 支架置入术 (FFRACAS) 装置，为血管内治疗界提供一种新型工具，无需 需要侵入性手术，并且会加速颈动脉支架植入，同时促进血流逆转。 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，既可作为长动脉导引鞘，又可作为闭塞球囊， 相对较小的外径和显着增加的内径因此，我们的系统的流动反转能力甚至更高。 无需双气球方法，与我们的丝绸之路一样好或更好。 拟议的设备将有助于更好、更安全、更快速地替代 CAS。 我们的具体目标是 1) 开发并执行我们的 FFRACAS 设备的体外试点测试，以及 2) 在我们的猪颈动脉模型中对 FFRACAS 装置进行迭代体内测试和验证。 FFRACAS 装置的主要目标是 1) 方便经皮放置，2) 实现 顺行血流无损伤停止，并且 3) 实现体内反向血流率等于或大于 CAS各阶段丝绸之路装置（逆流治疗的最佳标准） 第一阶段的这些目标的完成将为设计验证和开发铺平道路。 第二阶段的研究性新设备试验。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。