A Prospective, Multicenter, Randomized, Controlled Trial for Comparison of Drug-coated Balloon Versus Conventional Balloon Angioplasty in Venous Anastomotic Stenosis of Hemodialysis Graft
试验速览
- 阶段
- 4 期
- 入组人数
- 190
- 主要终点
- Primary patency (Fistulogram can be used for measurement of stenosis)
研究概览
简要总结
To evaluate the role of DCB angioplasty for venous anastomotic stenosis of hemodialysis graft, investigators would like to perform randomized study comparing the results of drug- coated balloon angioplasty with conventional balloon angioplasty in the treatment in venous anastomotic stenosis of AVG in terms of patency.
详细描述
Study Procedure The Interventional angiographic suit will follow the standard hemodialysis related interventional procedure for PTA. Fistulogram will be performed prior to PTA. All enrolled patients should undergo 3 and 6-month follow-up fistulogram and information will be collected and recorded on the treated study vessel and pictures through angiographic image. These data will be recorded on clinical recording form using an excel program.
- Pretreatment evaluation 1.1 All procedures will be performed after obtaining written informed consent from patients. No specific pre-treatment regimen will be needed.
1.2 After sterile preparation and draping, percutaneous access will be gained in an appropriately chosen hemodialysis graft after application of local anesthesia. Diagnostic fistulogram was performed to identify and evaluate the target lesion and any possible secondary lesions. In case of thrombotic occlusion of AVG, diagnostic fistulogram will be done after successful aspiration thrombectomy though a sheath.
1.3 All lesions were characterized by location, length, and degree of stenosis. The degree of stenoses was evaluated in two orthogonal planes, and the greatest degree of stenoses was used for subsequent anatomic measurements. Anatomic measurements were made with use of a calibrated reference marker or software within the angiographic imaging system. The reference vessel was defined as an adjacent segment of normal vein or graft located adjacent to the target lesion. The degree of stenosis was reported as the maximum diameter reduction compared with the reference vessel diameter. 2. PTA in venous anastomosis of AVG 2.1 Vascular sheaths will be used in all cases. 2.2 Balloon diameter will be chosen at the operator's discretion, generally starting with a balloon 10% oversized compared with the adjacent normal vein or graft in both groups (Reference Vessel Diameter: RVD).
2.3 Balloon length will be also chosen at the discretion of the operator: In general, 4-cm- or 6cm-long balloons can be used for some long lesions.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of more than 19
- •Hemodialysis patients with AVG in their arms: Graft should be implanted 30 days ago before enrollment
- •Vascular access actively used for hemodialysis: At least one hemodialysis successful session before enrollment.
- •Clinical signs of access dysfunction: decreased thrill, increased pulsatility, development collateral veins, limb swelling, difficulty in cannulation, prolonged bleeding after hemodialysis, high venous pressure or decreased hemodialysis flow rate during hemodialysis.
- •> 50% venous anastomotic stenosis of AVG, confirmed by fistulogram (angiography).
- •≦ 4cm from venous anastomosis site in lesion length
- •Reference diameter < 7mm of non-stenotic vessel or graft adjacent to venous stenosis.
- •Full expansion of conventional balloon during primary balloon angioplasty, confirmed by fluoroscopy.
- •Exclusion criteria
- •Patients unable to provide informed consent
- •Patient unable to abide with study follow-up protocol.
- •Patient participating in other relevant or conflicting studies
- •Bare metal stent or stent-graft placed previously
- •Hemodynamically significant stenosis of the central venous system
- •≧50% stenosis in arterial anastomotic site or venous outflow tract, non including venous anastomosis site
- •Stenosis with a corresponding thrombosis treated within 7 days before enrollment.
- •Limited life expectancy less than 6 months
- •Sepsis or active infection.
- •Recent arm thrombophlebitis (< 6months).
- •Allergy or other known contraindication to iodinated contrast media, heparin, or paclitaxel
- •Pregnancy or Nursing state
排除标准
- 未提供
结局指标
主要结局
Primary patency (Fistulogram can be used for measurement of stenosis)
时间窗: 6 months
次要结局
未报告次要终点
研究者
Sang Woo Park
Professor
Konkuk University Medical Center