Primary Patency in Post-angioplasty Dysfunctional Arteriovenous Fistula in Renal Dialysis: Paclitaxel-releasing PTA Balloon Catheter vs PTA Balloon

Fundación Pública Andaluza Progreso y Salud134 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

134

Conditions

Arteriovenous Fistula Renal Dialysis Devices Obstruction

Interventions

Paclitaxel-releasing PTA balloon catheter

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Freedom from target lesion revascularization

Percentage of patients that do not need any revascularization proceeding during the following twelve months after catheter insertion.

Time frame: 12 months