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

Primary Purpose

Arteriovenous Fistula Renal Dialysis Devices Obstruction

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Paclitaxel-releasing PTA balloon catheter
PTA balloon catheter
Sponsored by
Fundación Pública Andaluza Progreso y Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arteriovenous Fistula Renal Dialysis Devices Obstruction focused on measuring Vascular access devices obstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Universitario Puerto Real
  • Hospital Universitario Reina Sofía
  • Hospital Universitario Virgen de las Nieves
  • Hospital Universitario Juan Ramón Jiménez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Paclitaxel-releasing PTA balloon catheter

PTA Balloon catheter

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 30, 2015
Last Updated
February 21, 2019
Sponsor
Fundación Pública Andaluza Progreso y Salud
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1. Study Identification

Unique Protocol Identification Number
NCT02565953
Brief Title
Primary Patency in Post-angioplasty Dysfunctional Arteriovenous Fistula in Renal Dialysis: Paclitaxel-releasing PTA Balloon Catheter vs PTA Balloon
Acronym
FISBAL
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza Progreso y Salud

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistula Renal Dialysis Devices Obstruction
Keywords
Vascular access devices obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel-releasing PTA balloon catheter
Arm Type
Experimental
Arm Description
Treatment of renal dialysis arteriovenous fistula stenosis with paclitaxel-releasing percutaneous transluminal angioplastic (PTA) balloon catheter.
Arm Title
PTA Balloon catheter
Arm Type
Active Comparator
Arm Description
Treatment of renal dialysis arteriovenous fistula stenosis with percutaneous transluminal angioplastic (PTA) balloon catheter.
Intervention Type
Device
Intervention Name(s)
Paclitaxel-releasing PTA balloon catheter
Intervention Type
Device
Intervention Name(s)
PTA balloon catheter
Primary Outcome Measure Information:
Title
Freedom from target lesion revascularization
Description
Percentage of patients that do not need any revascularization proceeding during the following twelve months after catheter insertion.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Universitario Puerto Real
City
Puerto Real
State/Province
Cádiz
ZIP/Postal Code
11510
Country
Spain
Facility Name
Hospital Universitario Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital Universitario Juan Ramón Jiménez
City
Huelva
ZIP/Postal Code
21005
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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