Embolic Protection During Renal Artery Stenting

肾动脉支架置入术期间的栓塞保护

• 批准号: 7653786
• 负责人: MATTHEW S EDWARDS
• 金额: $ 10.84万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-10 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7653786
• 关键词: American; Angioplasty; Area; Arterial Fatty Streak; Balloon Angioplasty; Blood Pressure; Cardiovascular system; Cerebrovascular Circulation; Chronic Kidney Failure; Collaborations; Conduct Clinical Trials; Contrast Media; Coronary; Dependence; Development; Development Plans; Devices; Dialysis procedure; Disease; Distal; Doctor of Medicine; Elderly; End stage renal failure; Event; Fostering; Foundations; Freedom; Glomerular Filtration Rate; Goals; Individual; Inferior; Kidney; Kidney Diseases; Kidney Failure; Lead; Lesion; Medical; Mentored Patient-Oriented Research Career Development Award; Mentorship; Morbidity - disease rate; NIH Program Announcements; National Heart, Lung, and Blood Institute; Nephrotoxic; Operative Surgical Procedures; Outcome; Performance; Population; Positioning Attribute; Procedures; Public Health; Randomized Clinical Trials; Renal Blood Flow; Renal Circulation; Renal function; Research; Research Personnel; Retrieval; Role; Safety; Secondary Hypertension; Secondary to; Testing; Therapeutic Embolization; authority; blood pressure regulation; career; career development; design; experience; functional decline; functional improvement; improved; kidney vascular structure; mortality; particle; patient oriented research; prevent; programs; prospective; public health relevance; renal artery; response

DESCRIPTION (provided by applicant): This is an application for a NHLBI Mentored Patient Oriented Research Career Development Award in response to program announcement PA-00-004. This proposal will foster the scientific development of Dr. Matthew Edwards. The proposed career development plan incorporates a multi-disciplinary program of collaboration and mentorship under the direction of Drs. Kimberley Hansen, Charles McCall, and Robert Byington, internationally recognized authorities in the areas of renovascular disease (RVD), investigator development, and the conduct of clinical trials. This plan is designed to create a focused patient-oriented research experience that will provide the foundation for a successful, independent academic career. RVD is a recognized cause of severe secondary hypertension, progressive renal insufficiency, and endstage renal disease among the elderly who are the fastest growing subsegment of both the general and dialysis dependent populations. Angioplasty and stenting (PTAS) of the renal artery has demonstrated beneficial effects with regard to improving blood pressure control. However, a lower rate of improved renal function has been observed. This limitation is critical as renal function response following renal revascularization has been demonstrated to be a major determinant of subsequent cardiovascular morbidity and mortality as well as dialysis free survival. We hypothesize that the low rate of improved renal function is due to embolization of atheromatous debris liberated during the PTAS procedure. To test this hypothesis we propose a prospective, randomized clinical trial of distal embolic protection device (DEP) use during the performance of renal artery PTAS to maximize the renal function response following the procedure. The specific aims of this project will be 1) to examine the safety and efficacy of DEP to improve renal function and blood pressure response following renal artery PTAS and 2) To characterize the atheromatous debris prevented from passage into the kidney through the use of DEP. The public health relevance of this proposal relates to the improvement of a procedure which may be applicable to millions of Americans with the potential to improve renal function (and by extension subsequent survival free of dialysis dependence and adverse cardiovascular events). Currently, up to 45% of individuals undergoing renal artery PTAS experience inferior renal function results to those observed following surgical revascularization. These inferior results likely lead to inferior survival benefit. Therefore, provision of evidence that DEP improves the outcomes of renal artery PTAS has the potential to alter contemporary medical practice and favorably impact the dialysis-free survival for thousands of individuals each year.

描述（由申请人提供）： 这是NHLBI指导的以患者为导向的研究职业发展奖的申请 对计划公告PA-00-004的响应。该建议将促进马修·爱德华兹博士的科学发展。拟议的职业发展计划纳入了DRS的指导下的一项多学科协作和指导计划。金伯利·汉森（Kimberley Hansen），查尔斯·麦考尔（Charles McCall）和罗伯特·拜顿（Robert Byington）是肾血管疾病（RVD），研究者发展和临床试验的国际认可的当局。该计划旨在创造一个以患者为中心的研究经验，为成功的独立学术职业奠定了基础。 RVD是严重的继发性高血压，进行性肾功能不全以及终阶段肾脏疾病的公认原因，他们是一般和透析依赖人群中生长最快的子段。肾动脉的血管成形术和支架（PTA）在改善血压控制方面表现出有益的作用。但是，已经观察到较低的肾功能率。这种限制至关重要，因为肾脏血运重建后的肾功能反应已被证明是随后心血管发病率和死亡率以及无透析生存的主要决定因素。我们假设，肾功能的提高速率较低是由于PTAS过程中动脉瘤碎片的栓塞。为了检验这一假设，我们提出了在肾动脉PTA执行过程中远端栓塞装置（DEP）使用的前瞻性随机临床试验，以最大程度地提高手术后的肾功能反应。该项目的具体目的是1）检查DEP的安全性和功效，以改善肾动脉PTA后的肾功能和血压反应，以及2）表征动脉瘤的碎片，通过使用DEP阻止了动脉粥样硬化的碎片，从而阻止了通过使用DEP传递到肾脏中。 该提案的公共卫生相关性涉及改进该程序，该程序可能适用于数百万美国人，具有改善肾功能的潜力（并且随后扩展生存期，没有透析依赖性和不良心血管事件）。目前，多达45％的接受肾动脉PTA的个体经历了肾功能较低的结果，而肾功能比手术血运重建后观察到的结果下。这些劣等的结果可能导致生存率较低。因此，提供DEP改善肾动脉PTA结果的证据有可能改变当代医学实践，并有利地影响了每年成千上万个人的无透析生存。