NCT03189667终止不适用
Drug Coated Balloons vs Plain Balloons for the Management of Dysfunctional Dialysis Fistula
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- AVF circuit patency
研究概览
简要总结
Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis arteriovenous fistulas (AVFs).
详细描述
Objectives of the Study:
Hypothesis: Drug-coated balloons improve functional and patency outcomes of failing/dysfunctional hemodialysis fistulas compared to plain uncoated balloons
Aim of the Study:
Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis AVFs.
Specific Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria
- •>18 year old
- •Dysfunctional dialysis fistula
- •Radiocephalic
- •Brachiocephalic
- •Brachiobasilic
- •Clinical criteria for diagnosis of dysfunctional fistula:
- •Swelling of the fistula limb
- •Prolonged bleeding after withdrawing access needles
- •Abnormal pulsations or weak thrill.
- •Functional criteria for the diagnosis of dysfunctional criteria:
- •Arteriovenous fistula is unable to deliver dialysis blood flow (Qb) of equal to or more than 300 ml/min and/or access recirculation of more than 10% on at least two occasions,
- •A rising trend of venous pressure or excessive negative arterial pressure, and/or unable to deliver a Kt/v of 1.2 or more.
- •Non-thrombosed
排除标准
- •Dysfunctional arteriovenous (AV) grafts
- •Thrombosed fistulas
- •Intra-stent stenosis
- •Stenoses not responding to balloon angioplasty and requiring stenting.
- •Stenosis less than 50%
- •Surgical intervention that excludes the treatment segment from the access circuit
- •Systemic or local (to the fistula) infection treated for less than 10 days prior to the study procedure
- •Location of isolated stenosis central to the thoracic inlet.
- •Women who are breastfeeding, pregnant or are intending to become pregnant
- •Known hypersensitivity or contraindication to contrast medium which cannot be adequately premeditated.
- •Sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel
研究组 & 干预措施
Drug coated balloon angioplasty
Experimental
- Vessel preparation with Pre dilatation
- Vessel treatment with Drug-coated balloon
干预措施: Vessel preparation with angioplasty (Device)
Drug coated balloon angioplasty
Experimental
- Vessel preparation with Pre dilatation
- Vessel treatment with Drug-coated balloon
干预措施: Drug coated balloon angioplasty (Device)
Plain balloon angioplasty
Active Comparator
- Vessel preparation with Pre dilatation
- Vessel treatment with additional Plain balloon angioplasty:
干预措施: Vessel preparation with angioplasty (Device)
Plain balloon angioplasty
Active Comparator
- Vessel preparation with Pre dilatation
- Vessel treatment with additional Plain balloon angioplasty:
干预措施: Plain balloon angioplasty (Device)
结局指标
主要结局
AVF circuit patency
时间窗: 12 month
Dialysis adequacy to be assessed based on functional criteria
次要结局
- Technical success(intra procedural)
- Target lesion restenosis free survival(12 month)
- Access circuit dysfunction free survival(12 month)
- Number of participants with treatment-related adverse events(12 month following the procedure)
研究者
研究点 (2)
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