Comparison of peripheral cutting balloon versus conventional balloon angioplasty for hemodialysis vascular access stenosis ~prospective randomized controlled trial~
Not Applicable
Recruiting
- Conditions
- Hemodialysis vascular access stenosis
- Registration Number
- JPRN-UMIN000009556
- Lead Sponsor
- Shizuoka General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 374
Inclusion Criteria
Not provided
Exclusion Criteria
1.Patient incapable of providing written informed consent 2.Life expectancy <6 months 3.Severe allergy to contrast medium 4.Active vascular access infection 5.Pregnancy 6.A Stent placed at the target lesion 7.An angulation of target lesion >=45 degrees 8.The reference vessel diameter <2mm 9.The target stenosis >20mm in length 10.Total occlusion 11.Severe calcification of target lesion 12.Junctional lesion needed for double guide-wire technique 13.Target lesion with branches unable to protect 14.Severely tortuous vessel proximal to the lesion 15.Multiple stenotic lesion needed for multiple sheath insertion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 6-month primary patency rate
- Secondary Outcome Measures
Name Time Method Duration of primary patency of the hemodialysis vascular access (Treatment area primary patency and access circuit primary patency) Complication Anatomical success Clinical success Procedural success Ultrasonographic finding before and after PTA(Percutaneous transluminal angioplasty) Subjective assessment of pain during balloon-cathether inflation Ultrasonographic finding at 3 months and 6 months after the intervention Angiography at 6 months