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

Arteriovenous Fistula Renal Dialysis Devices Obstruction Clinical Trial

— FISBAL  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565953
• Other study ID #: FISBAL
• Status: Completed
• Phase: Phase 3
• Start date: October 2015
• Est. completion date: October 2018

Study information

• Verified date: March 2017
• Source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Arteriovenous Fistula Renal Dialysis Devices Obstruction
• Fistula

Intervention

Device:
• Paclitaxel-releasing PTA balloon catheter

• PTA balloon catheter

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza Progreso y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from target lesion revascularization	Percentage of patients that do not need any revascularization proceeding during the following twelve months after catheter insertion.	12 months