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OpenTrials
Completed

NCT Number: NCT02565953

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

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.

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Key information

Conditions

Arteriovenous Fistula Renal Dialysis Devices Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario Puerto Real, Puerto Real, Cádiz, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paclitaxel-releasing PTA balloon catheter

Device

PTA balloon catheter

Device

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza Progreso y Salud

Other

Registry information

Acronym: FISBAL

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 1, 2015
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.