Schwarzwälder Uwe, Hauk Michael, Zeller Thomas
Department Angiology, Herz-Zentrum Bad Krozingen, Südring 15, 79189 Bad Krozingen, Germany.
Trials. 2009 Jul 27;10:60. doi: 10.1186/1745-6215-10-60.
Prospective, international, multi-centre, randomised (1:1) trial to evaluate the clinical impact of percutaneous transluminal renal artery stenting (PTRAS) on the impaired renal function measured by the estimated glomerular filtration rate (eGFR) in patients with haemodynamically significant atherosclerotic renal artery stenosis.
Patients will be randomised to receive either PTRAS using the Dynamic Renal Stent system plus best medical treatment or best medical treatment. Renal stenting will be performed under angiographic imaging. For patients randomised to best medical treatment the degree of stenosis measured by renal duplex sonography (RDS) will be confirmed by MR angio or multi-slice CT where possible. Best medical treatment will be initiated at randomisation or post procedure (for PTRAS arm only), and adjusted as needed at all visits. Best medical treatment is defined as optimal drug therapy for control of the major risk factors (blood pressure < or = 125/80 mmHg, LDL cholesterol < or = 100 mg/dL, HbA1c < or = 6.5%). Data recordings include serum creatinine values, eGFR, brain natriuretic peptide, patients' medical history and concomitant medication, clinical events, quality of life questionnaire (SF-12v2), 24 hour ambulatory blood pressure measurement, renal artery duplex ultrasound and echocardiography. Follow-up intervals are at 2, 6, 12 and 36 months following randomisation.The primary endpoint is the difference between treatments in change of eGFR over 12 months. Major secondary endpoints are technical success, change of renal function based on the eGFR slope change between pre-treatment and post-treatment (i.e. improvement, stabilisation, failure), clinical events overall such as renal or cardiac death, stroke, myocardial infarction, hospitalisation for congestive heart failure, progressive renal insufficiency (i.e. need for dialysis), need of target vessel revascularisation or target lesion revascularisation, change in average systolic and diastolic blood pressure, change in left ventricular mass index calculated from echocardiography, difference in the size of kidney (pole to pole length) measured by renal duplex sonography, total number, drug name, drug class, daily dose, regimen and Defined Daily Dose (DDD), of anti-hypertensive drugs, and change in New York Heart Association (NYHA) classification. Approximately 30 centres in Europe and South America will enrol patients. Duration of enrolment is expected to be 12 months resulting in study duration of 48 months.
NCT00640406.
一项前瞻性、国际性、多中心、随机（1:1）试验，旨在评估经皮腔内肾动脉支架置入术（PTRAS）对血流动力学显著的动脉粥样硬化性肾动脉狭窄患者估算肾小球滤过率（eGFR）所衡量的肾功能损害的临床影响。
患者将被随机分为接受使用动态肾支架系统加最佳药物治疗的PTRAS组或最佳药物治疗组。肾支架置入术将在血管造影成像下进行。对于随机分配至最佳药物治疗组的患者，尽可能通过磁共振血管造影或多层CT确认经肾双功超声（RDS）测量的狭窄程度。最佳药物治疗将在随机分组时或术后（仅针对PTRAS组）开始，并在每次随访时根据需要进行调整。最佳药物治疗定义为控制主要危险因素的最佳药物治疗（血压≤125/80 mmHg，低密度脂蛋白胆固醇≤100 mg/dL，糖化血红蛋白≤6.5%）。数据记录包括血清肌酐值、eGFR、脑钠肽、患者病史和伴随用药、临床事件、生活质量问卷（SF - 12v2）、24小时动态血压测量、肾动脉双功超声和超声心动图。随访间隔为随机分组后的2、6、12和36个月。主要终点是12个月内治疗组间eGFR变化的差异。主要次要终点包括技术成功率、基于治疗前和治疗后eGFR斜率变化的肾功能变化（即改善、稳定、失败）、总体临床事件，如肾或心源性死亡、中风、心肌梗死、因充血性心力衰竭住院、进行性肾功能不全（即需要透析）、靶血管再血管化或靶病变再血管化的需求、平均收缩压和舒张压的变化、根据超声心动图计算的左心室质量指数的变化、通过肾双功超声测量的肾脏大小（极到极长度）的差异、抗高血压药物的总数、药物名称、药物类别、每日剂量、用药方案和限定日剂量（DDD），以及纽约心脏协会（NYHA）分级的变化。欧洲和南美洲约30个中心将招募患者。预计入组时间为12个月，研究持续时间为48个月。
NCT00640406。
