Treatment with stenosis in the vascular access for dialysis in adult patients using percutaneous transluminal angioplasty Surgery
Conditions
Interventions
The aim of this study was to evaluate if adult patients with stenosis in dialysis vascular access would benefit from the use of a drug-eluting balloon.
The patients are referred from d
Sponsors
Charles University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged >18 years old 2. Life expectancy >1 year 3. Clinically mature dialysis fistula (AVG or AVF) already used for hemodialysis with adequate pump speed and dialysis efficacy for at least 4 consecutive sessions with the two-needle technique 4. Signs of fistula dysfunction (absent thrill, low flow, high venous pressure, high pulsatility, needling problems, abnormal pulsatility, abnormal auscultation, extremity edema, etc) 5. Hemodynamically significant (>50%) stenosis in juxta-anastomotic or outflow vein of AVF (excluding central veins defined as veins medial to the lateral margin of the first rib) or in the venous anastomosis, juxta-anastomotic segment or outflow vein in AVG (excluding central veins).
Exclusion criteria
Exclusion criteria: 1. Access circuit thrombosis in the last year 2. History of graft infection 3. Prior use of a drug-eluting balloon catheter in the access circuit 4. In-stent restenosis in bare metal or covered stent 5. Angiography contraindications (e.g. severe contrast media allergy) 6. Two or more distinct significant stenoses in the access circuit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency rates measured using angiography and the need for repeated intervention at 3, 6, 9, 12 months or earlier if requested by the physician | — |
Secondary
| Measure | Time frame |
|---|---|
| Median time to target lesion re-intervention measured using medical records and angiography at 3, 6, 9, 12 months or earlier if requested by the physician | — |
Countries
Czech Republic
Outcome results
None listed