Paclitaxel-Coated versus Plain Balloon Angioplasty for Dysfunctional Autogenous Radiocephalic Arteriovenous Fistulas
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0004870
- Lead Sponsor
- Gachon University Gil Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
1. Patients with radiocephalic arteriovenous fistula (RCAVF) for hemodialysis
2. Patients who have been diagnosed with dysfunctional RCAVF and have been referred for balloon angioplasty
3. Lesions (de novo or restenosis) located at a juxta-anastomotic venous site within 8 cm of the anastomotic point of a RCAVF
4. Fistulographic confirmation of stenosis greater than 50% (vs. proximal reference diameter)
1. Dialysis access type other than RCAVFs
2. Thrombosed RCAVFs
3. Evidence of systemic or local infection associated with the RCAVF
4. Life expectancy <1 year
5. Allergy or other known contraindications to iodinated contrast media or paclitaxel
6. Age <19 years
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method technical success;clinical success;target lesion primary patency
- Secondary Outcome Measures
Name Time Method target lesion secondary patency;procedure-related complication