Balloon Angioplasty in Venous Anastomotic Stenoses of Hemodialysis Graft
- Conditions
- Not Applicable
- Registration Number
- KCT0003654
- Lead Sponsor
- Soon Chun Hyang University Hospital Seoul
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 190
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Patency in the treated lesion at 6 months, Comparison of MACE and complications, between DCB and conventional Balloon angioplasty group.
- Secondary Outcome Measures
Name Time Method Target Circuit Revascularization (TCR) and Overall dialysis graft survival at 6 months, Comparison of technical success and clinical success between two groups.