Primary Patency in Post-angioplasty Dysfunctional Arteriovenous Fistula in Renal Dialysis: Paclitaxel-releasing PTA Balloon Catheter vs PTA Balloon
NCT ID: NCT02565953
Last Updated: 2019-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
134 participants
INTERVENTIONAL
2015-10-31
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Paclitaxel-releasing PTA balloon catheter
Treatment of renal dialysis arteriovenous fistula stenosis with paclitaxel-releasing percutaneous transluminal angioplastic (PTA) balloon catheter.
Paclitaxel-releasing PTA balloon catheter
PTA Balloon catheter
Treatment of renal dialysis arteriovenous fistula stenosis with percutaneous transluminal angioplastic (PTA) balloon catheter.
PTA balloon catheter
Interventions
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Paclitaxel-releasing PTA balloon catheter
PTA balloon catheter
Eligibility Criteria
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Inclusion Criteria
* Patient diagnosed with AVF stenosis by clinical and radiological criteria
* Sign informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Fundación Pública Andaluza Progreso y Salud
OTHER
Responsible Party
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Locations
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Hospital Universitario Puerto Real
Puerto Real, Cádiz, Spain
Hospital Universitario Reina Sofía
Córdoba, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital Universitario Juan Ramón Jiménez
Huelva, , Spain
Countries
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Other Identifiers
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FISBAL
Identifier Type: -
Identifier Source: org_study_id
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