A Prospective, Multicenter, Randomized, Controlled Trial for Comparison of Drug-eluting Balloon versus Conventional Balloon Angioplasty in Venous Anastomotic Stenoses of Hemodialysis Graft

Soon Chun Hyang University Hospital Seoul0 个研究点目标入组 190 人开始时间: 待定最近更新: 2019年3月25日

试验速览

暂无简介。

•1. Age of more than 19, hemodialysis patients with AVG in their arms: Graft should be implanted 30 days ago before enrollment.
•2. Vascular access actively used for hemodialysis: At least one hemodialysis successful session before enrollment.
•3. 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.
•4. > 50% venous anastomotic stenosis of AVG, confirmed by fistulogram (angiography).
•5. ?4cm from venous anastomosis site in lesion length
•6. Reference diameter < 7mm of non-stenotic vessel or graft adjacent to venous stenosis.
•7. Full expansion of conventional balloon during primary balloon angioplasty, confirmed by fluoroscopy.

•1. Patients unable to provide informed consent
•2. Patient unable to abide with study follow-up protocol.
•3. Patient participating in other relevant or conflicting studies
•4. Bare metal stent or stent-graft placed previously
•5. Hemodynamically significant stenosis of the central venous system
•6. ?50% stenosis in arterial anastomotic site or venous outflow tract, non including venous anastomosis site
•7. Stenosis with a corresponding thrombosis treated within 7 days before enrollment.
•8. Limited life expectancy less than 6 months
•9. Sepsis or active infection.
•10. Recent arm thrombophlebitis (< 6months).
•11. Allergy or other known contraindication to iodinated contrast media, heparin, or paclitaxel
•12. Pregnancy or Nursing state.

发起方

Soon Chun Hyang University Hospital Seoul