Primary Patency in Post-angioplasty Dysfunctional Arteriovenous Fistula in Renal Dialysis: Paclitaxel-releasing PTA Balloon Catheter vs PTA Balloon
- Conditions
- Arteriovenous Fistula Renal Dialysis Devices Obstruction
- Registration Number
- NCT02565953
- Lead Sponsor
- Fundación Pública Andaluza Progreso y Salud
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Hospital Universitario Puerto Real
🇪🇸Puerto Real, Cádiz, Spain
Hospital Universitario Reina Sofía
🇪🇸Córdoba, Spain
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Universitario Juan Ramón Jiménez
🇪🇸Huelva, Spain
Hospital Universitario Puerto Real🇪🇸Puerto Real, Cádiz, Spain