CLINICAL TRIAL: CLINICAL TRIAL OF DISTAL EMBOLIC PROTECTION DURING RENAL ARTERY

临床试验：肾动脉远端栓塞保护的临床试验

• 批准号: 7951378
• 负责人: MATTHEW S EDWARDS
• 金额: $ 0.19万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2010-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951378
• 关键词: Angioplasty; Arterial Fatty Streak; Blood Pressure; Cardiovascular system; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Dependence; Devices; Dialysis procedure; Disease; Distal; Elderly; End stage renal failure; Funding; Grant; Institution; Kidney; Kidney Failure; Morbidity - disease rate; Population; Randomized Clinical Trials; Renal function; Research; Research Personnel; Resources; Safety; Secondary Hypertension; Secondary to; Source; Testing; Therapeutic Embolization; United States National Institutes of Health; blood pressure regulation; improved; kidney vascular structure; mortality; prevent; prospective; renal artery; response

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Atherosclerotic renovascular disease is a recognized cause of severe secondary hypertension, progressive renal insufficiency, and end-stage renal disease among the elderly who make up the fastest growing subsegment of both the general and dialysis dependent populations. Angioplasty and stenting (PTAS) of the renal artery has shown beneficial effects with regards to blood pressure control. However, a low rate of beneficial renal function response has been observed. This limitation is critical as renal function response following renal revascularization has been demonstrated to be the major determinant of improved cardiovascular morbidity and mortality and survival free of dialysis dependence. The low rate of beneficial renal function response may be secondary to embolization of atheromatous debris liberated during PTAS. We hypothesize that renal embolization can be reduced through the use of a distal renal artery embolic protection device (DEP) and will improve the long-term benefits of renal artery PTAS. To test this hypothesis we propose a prospective, randomized clinical trial. The specific aims of this project will be 1) to examine the safety and efficacy of DEP to improve renal function response and blood pressure response following renal artery PTAS and 2) To characterize the atheromatous debris prevented from passage into the kidney using DEP.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 动脉粥样硬化的肾血管疾病是严重的继发性高血压，进行性肾脏不足以及终末期肾脏疾病的公认原因，他们构成了一般和透析依赖人群中增长最快的子段。肾动脉的血管成形术和支架（PTA）在血压控制方面已显示出有益的作用。但是，已经观察到较低的有益肾功能反应率。这种局限性至关重要，因为肾脏血运重建后的肾功能反应已被证明是改善心血管发病率和死亡率以及无透析依赖性的生存的主要决定因素。较低的有益肾功能反应率可能是栓塞在PTA期间释放的动脉瘤碎片的继发。我们假设可以通过使用远端肾动脉保护装置（DEP）来减少肾脏栓塞，并将改善肾动脉PTA的长期益处。为了检验该假设，我们提出了一项前瞻性，随机临床试验。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后的肾功能反应和血压反应和2）表征，以使用DEP来阻止动脉瘤碎片阻止进入肾脏。