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Paclitaxel-Coated versus Plain Balloon Angioplasty for Dysfunctional Autogenous Radiocephalic Arteriovenous Fistulas

Not Applicable
Completed
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
Inclusion Criteria

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)

Exclusion Criteria

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
NameTimeMethod
technical success;clinical success;target lesion primary patency
Secondary Outcome Measures
NameTimeMethod
target lesion secondary patency;procedure-related complication
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