Arteriovenous Fistula Renal Dialysis Devices Obstruction
Conditions
Keywords
Vascular access devices obstruction
Brief summary
In recent years the use of paclitaxel releasing percutaneous transluminal angioplastic (PTA) balloon catheter is spreading in vascular pathology, mainly in stenosis infrainguinal arteries. This device combined the mechanical action of PTA balloon with the antiproliferative effects of paclitaxel. The use of these devices in venous pathology is limited. This devices could improve the treatment of renal dialysis arteriovenous fistula stenosis.
Interventions
DEVICEPaclitaxel-releasing PTA balloon catheter
DEVICEPTA balloon catheter
Sponsors
Fundación Pública Andaluza Progreso y Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with renal dialysis with arteriovenous fistula (AVF) at least 3 months before. * Patient diagnosed with AVF stenosis by clinical and radiological criteria * Sign informed consent
Exclusion criteria
* Pregnant or breastfeeding * Patients with AVF stenosis not could be treated with PTA catheter * Paclitaxel allergy * Iodinated contrast allergy * Local or systemic active infection * Life expectancy less than 12 moths
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from target lesion revascularization | 12 months | Percentage of patients that do not need any revascularization proceeding during the following twelve months after catheter insertion. |
Countries
Spain
Outcome results
None listed