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

Fundación Pública Andaluza Progreso y Salud

Status and phase: Completed; Phase 3

Conditions: Arteriovenous Fistula Renal Dialysis Devices Obstruction

Treatments: Device: PTA balloon catheter; Device: Paclitaxel-releasing PTA balloon catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02565953

FISBAL

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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134 participants in 2 patient groups

Paclitaxel-releasing PTA balloon catheter

Experimental group

Description:

Treatment of renal dialysis arteriovenous fistula stenosis with paclitaxel-releasing percutaneous transluminal angioplastic (PTA) balloon catheter.

Treatment:

Device: Paclitaxel-releasing PTA balloon catheter

PTA Balloon catheter

Active Comparator group

Description:

Treatment of renal dialysis arteriovenous fistula stenosis with percutaneous transluminal angioplastic (PTA) balloon catheter.

Treatment:

Device: PTA balloon catheter