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首页> 外文期刊>Trials >Paclitaxel-coated balloon fistuloplasty versus plain balloon fistuloplasty only to preserve the patency of arteriovenous fistulae used for haemodialysis (PAVE): study protocol for a randomised controlled trial
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Paclitaxel-coated balloon fistuloplasty versus plain balloon fistuloplasty only to preserve the patency of arteriovenous fistulae used for haemodialysis (PAVE): study protocol for a randomised controlled trial

机译：紫杉醇涂层球囊造瘘术与普通球囊造瘘术仅能保持动静脉瘘用于血液透析（PAVE）的通畅性：一项随机对照试验的研究方案

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Background The initial therapy for a stenosis in an arteriovenous fistula used for haemodialysis is radiological balloon dilatation or angioplasty. The benefit of angioplasty is often short-lived, intervention-free survival is reported to be 40–50?% at 1?year. Previous small studies and observational data suggest that paclitaxel-coated balloons may be of benefit in improving outcomes after fistuloplasty of stenotic arteriovenous fistulae. Methods/design We have designed a multicentre, double-blind randomised controlled trial to test the superiority of paclitaxel-coated balloons for preventing restenosis after fistuloplasty in patients with a native arteriovenous fistula. Two hundred and eleven patients will be followed up for a minimum of 1?year. Inclusion criteria include a clinical indication for a fistuloplasty, an access circuit that is free of synthetic graft material or stents, and a residual stenosis of 30?% or less after plain balloon fistuloplasty. Exclusion criteria include a synchronous venous lesion in the same access circuit, location of the stenosis central to the thoracic inlet or a thrombosed access circuit at the time of treatment. The primary endpoint is time to end of target lesion primary patency. This is defined as a clinically-driven radiological or surgical re-intervention at the treatment segment, thrombosis that includes the treatment segment, or abandonment of the access circuit due to an inability to re-treat the treatment segment. Secondary endpoints include angiographic late lumen loss, time to end of access circuit cumulative patency, the total number of interventions, and quality of life. The trial is funded by the National Institute for Health Research. Discussion We anticipate that this trial will provide rigorous data that will determine the efficacy of additional paclitaxel-coated balloon fistuloplasty versus plain balloon fistuloplasty only to preserve the patency of arteriovenous fistulae used for haemodialysis. Trial registration ISRCTN14284759 . Registered on 28 October 2015.
机译：背景技术用于血液透析的动静脉瘘狭窄的初始治疗是放射球囊扩张或血管成形术。血管成形术的益处通常是短暂的，据报道在1年时无干预生存率为40–50％。先前的小型研究和观察数据表明，紫杉醇涂层的球囊可能对改善狭窄的动静脉瘘的瘘管成形术后的预后有帮助。方法/设计我们设计了一项多中心，双盲，随机对照试验，以测试紫杉醇涂层球囊预防天然动静脉瘘患者瘘管成形术后再狭窄的优越性。 211名患者将接受至少1年的随访。纳入标准包括瘘管成形术的临床指征，无合成移植物材料或支架的进入回路，以及普通球囊瘘管成形术后的残余狭窄率为30％或更少。排除标准包括在同一通路中出现同步静脉病变，在治疗时狭窄位置位于胸腔入口中央或血栓形成的通路中。主要终点是目标病变主要通畅时间。这被定义为在治疗段的临床驱动的放射学或手术再干预，包括治疗段的血栓形成或由于无法重新治疗段而导致的进入回路的放弃。次要终点包括血管造影术的晚期管腔丢失，进入回路结束的时间累积通畅，干预的总数和生活质量。该试验由美国国立卫生研究院资助。讨论我们预计，该试验将提供严格的数据，这些数据将确定其他紫杉醇涂层球囊造瘘术与普通球囊造瘘术的疗效，仅能保持动静脉瘘用于血液透析的通畅性。试用注册ISRCTN14284759。 2015年10月28日注册。

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