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

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ClinicalTrials.gov Identifier: NCT02565953
Recruitment Status : Completed
First Posted : October 1, 2015
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( Fundación Pública Andaluza Progreso y Salud )

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.

Condition or disease Intervention/treatment Phase
Arteriovenous Fistula Renal Dialysis Devices Obstruction Device: Paclitaxel-releasing PTA balloon catheter Device: PTA balloon catheter Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2015
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Fistulas
Drug Information available for: Paclitaxel

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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565953


Locations
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Spain
Hospital Universitario Puerto Real
Puerto Real, Cádiz, Spain, 11510
Hospital Universitario Reina Sofía
Córdoba, Spain, 14004
Hospital Universitario Virgen de las Nieves
Granada, Spain, 18014
Hospital Universitario Juan Ramón Jiménez
Huelva, Spain, 21005
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud

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Responsible Party: Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT02565953     History of Changes
Other Study ID Numbers: FISBAL
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: March 2017

Keywords provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( Fundación Pública Andaluza Progreso y Salud ):
Vascular access devices obstruction

Additional relevant MeSH terms:
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Vascular Malformations
Fistula
Arteriovenous Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action