Murphy Timothy P, Hirsch Alan T, Cutlip Donald E, Regensteiner Judith G, Comerota Anthony J, Mohler Emile, Cohen David J, Massaro Joseph
Rhode Island Hospital Vascular Disease Research Center and Brown Medical School Department of Diagnostic Imaging, Providence, RI 02903, USA.
J Vasc Surg. 2009 Oct;50(4):942-945.e2. doi: 10.1016/j.jvs.2009.04.076. Epub 2009 Aug 5.
The Claudication: Exercise vs Endoluminal Revascularization (CLEVER) Study is a prospective multicenter randomized clinical trial designed to compare the relative clinical and cost-effectiveness of invasive revascularization with stents to supervised exercise rehabilitation in a cohort with moderate to severe claudication due to aortoiliac insufficiency. The study is currently enrolling at twenty-eight sites in the US and Canada. Enrollment of 217 participants is planned, with data collected at baseline, six months, and 18 months. The primary study endpoint is maximum walking duration (MWD) on a graded treadmill test; secondary endpoints include community-based walking, markers of cardiovascular disease risk (body mass index, waist circumference, blood pressure, lipid profile, glucose tolerance, and plasma fibrinogen), health-related quality of life, and cost effectiveness. There are currently sixty randomized participants; recruitment is projected to end in July 2010 and final study results reported in June 2012.
运动与腔内血管重建术（CLEVER）研究是一项前瞻性多中心随机临床试验，旨在比较在因主髂动脉功能不全导致中度至重度间歇性跛行的队列中，使用支架进行侵入性血管重建术与接受监督的运动康复治疗的相对临床效果和成本效益。该研究目前正在美国和加拿大的28个地点招募患者。计划招募217名参与者，并在基线、6个月和18个月时收集数据。主要研究终点是分级跑步机测试中的最大步行持续时间（MWD）；次要终点包括基于社区的步行、心血管疾病风险标志物（体重指数、腰围、血压、血脂谱、糖耐量和血浆纤维蛋白原）、健康相关生活质量和成本效益。目前已有60名参与者被随机分组；预计招募工作将于2010年7月结束，最终研究结果将于2012年6月公布。
