None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : 1. Devices
1) Paclitaxel-coated balloon angioplasty group (DBA group): 4-mm or 5-mm IN.PACT Admiral paclitaxel-eluting balloon catheters (Medtronic, Italy) and 4-mm
lidocaine), and a 6- or 7-F vascular sheath (Radiofocus
Terumo, Tokyo, Japan) was placed in the retrograde direction.
5) Heparin was administered at a dose of 2500 IU. Through this sheath, a 5-F Kumpe catheter (Cook Medical, Bloomington, IN, USA) and 0.035
Sponsors
Gachon University Gil Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| technical success;clinical success;target lesion primary patency | — |
Secondary
| Measure | Time frame |
|---|---|
| target lesion secondary patency;procedure-related complication | — |
Countries
Korea, Republic of
Contacts
Public ContactJong Woo Kim
Asan Medical Center
Outcome results
None listed