NCT02266238Unknown不适用
Randomized Controlled Trial to Compare Therapeutic Effect of Digital Subtraction Angiography(DSA)，Ultrasound Guided Balloon Dilatation and Surgical Reconstruction in Arteria-venous Fistula(AVF) Stenosis in Maintenance Hemodialysis Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- the patency rate of the AVF after intervention
研究概览
简要总结
The purpose of this study is to compare the effect of DSA guided percutaneous balloon dilatation, ultrasound guided percutaneous balloon dilatation and surgical repair in the treatment of Stenosis of Arteria-Venous Fistula in Maintenance Hemodialysis Patients.
详细描述
Eligibility Criteria:
- Patients with long-term maintenance hemodialysis with AVF as the vascular access;
- Positive clinical examination signs of AVF stenosis （not all required） : (1) the visual examination: edema, prolonged bleeding time, hematoma, aneurysm or constriction of the fistula .(2) the palpation examination: a narrowing of the outflow vein or aneurysm formation. (3) the auscultation examination: high pitch and/or discontinuous murmur.
- Doppler ultrasound /DSA/magnetic resonance angiography show the diameter of AVF fistula is >50% narrow than the adjacent segment of the fistula lumen.
- Blood flow of the AVF is <500ml/min or monthly declines of the blood flow>25%.
- Patient signed the informed consent.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with long-term maintenance hemodialysis with AVF as the vascular access;
- •Positive clinical examination signs of AVF stenosis （not all required） : (1) the visual examination: edema, prolonged bleeding time, hematoma, aneurysm or constriction of the fistula .(2) the palpation examination: a narrowing of the outflow vein or aneurysm formation. (3) the auscultation examination: high pitch and/or discontinuous murmur;
- •Doppler ultrasound /DSA/MRA show the diameter of AVF fistula is >50% narrow than the adjacent segment of the fistula lumen;
- •Blood flow of the AVF is <500ml/min or monthly declines of the blood flow>25%;
- •Patient signed the informed consent.
排除标准
- •allergic to the iodine contrast or gadolinium contrast agent;
- •local infection;
- •the presence of severe coagulation dysfunction (or long-term history of taking warfarin or ticlopidine);
- •the presence of severe artery steal syndrome;
- •stenosis of immature fistula or fistula <2 month after vascular anastomosis;
- •severe central venous stenosis;
- •discontinue hemodialysis treatment (such as to transfer to peritoneal dialysis or kidney transplant);
- •severe cardiac dysfunction (New York Heart Association cardiac functional classification III or worse), unstable angina pectoris, myocardial infarction, severe left ventricular hypertrophy, or severe vascular embolic disease;
- •participated in other clinical trials within 12 weeks;
- •alcohol and/or drug abusers, mental disorders;
- •patients not suitable as the subjects of this trial under the consideration of researchers.
研究组 & 干预措施
Group 1
Experimental
DSA guided percutaneous balloon dilatation to expand the stenosis of arteriovenous fistula
干预措施: DSA guided percutaneous balloon dilatation (Device)
Group 2
Experimental
Ultrasound guided percutaneous balloon dilatation to expand the stenosis of arteriovenous fistula
干预措施: Ultrasound guided percutaneous balloon dilatation (Device)
Group 3
Experimental
Surgical reconstruction of the stenosis to reconstruction the lumen of arteriovenous fistula
干预措施: Surgical reconstruction (Procedure)
结局指标
主要结局
the patency rate of the AVF after intervention
时间窗: 24 month
the patency rate including the primary and the secondary patency rate
次要结局
- The cost-effectiveness analysis of AVF stenosis interventions(24 month)
- The success rate of AVF stenosis interventions(24 month)
- The recurrence rate of AVF stenosis interventions(24 month)
- The side effects of AVF stenosis interventions(24 month)
研究者
Changlin Mei
Professor, Director, Division of Nephrology
Shanghai Changzheng Hospital
研究点 (1)
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