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

February 21, 2019 updated by: Fundación Pública Andaluza Progreso y Salud
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves
      • Huelva, Spain, 21005
        • Hospital Universitario Juan Ramon Jimenez
    • Cádiz
      • Puerto Real, Cádiz, Spain, 11510
        • Hospital Universitario Puerto Real

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paclitaxel-releasing PTA balloon catheter
Treatment of renal dialysis arteriovenous fistula stenosis with paclitaxel-releasing percutaneous transluminal angioplastic (PTA) balloon catheter.
Device: Paclitaxel-releasing PTA balloon catheter
Active Comparator: PTA Balloon catheter
Treatment of renal dialysis arteriovenous fistula stenosis with percutaneous transluminal angioplastic (PTA) balloon catheter.
Device: PTA balloon catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from target lesion revascularization
Time Frame: 12 months
Percentage of patients that do not need any revascularization proceeding during the following twelve months after catheter insertion.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza Progreso y Salud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

September 30, 2015

First Submitted That Met QC Criteria

September 30, 2015

First Posted (Estimate)

October 1, 2015

Study Record Updates

Last Update Posted (Actual)

February 22, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FISBAL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arteriovenous Fistula Renal Dialysis Devices Obstruction

Clinical Trials on Paclitaxel-releasing PTA balloon catheter

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe