NCT02565953|CompletedPhase 3
Primary Patency in Post-angioplasty Dysfunctional Arteriovenous Fistula in Renal Dialysis: Paclitaxel-releasing PTA Balloon Catheter vs PTA Balloon
FISBAL
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FISBAL
Sponsor study identifier
interventional
134
1 country
4
Study Start
October 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2018
Actual (reported)Study Completion
October 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 30, 2015
Actual (reported)October 2015
Date type not reportedThis date has not been verified as actual or estimated.
October 1, 2015
Actual (reported)October 2018
Actual (reported)October 2018
Actual (reported)Freedom from target lesion revascularization
Percentage of patients that do not need any revascularization proceeding during the following twelve months after catheter insertion.
12 months
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital Universitario Puerto Real
Puerto Real, Cádiz, 11510, Spain
Hospital Universitario Reina Sofía
Córdoba, 14004, Spain
Hospital Universitario Virgen de las Nieves
Granada, 18014, Spain
Hospital Universitario Juan Ramón Jiménez
Huelva, 21005, Spain
134 participants (actual enrollment reported by the registry).
First Submitted
September 30, 2015
First Posted
October 1, 2015
Study Start
October 2015
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
October 2018
Actual (reported)Study Completion
October 2018
Actual (reported)Last Updated
February 22, 2019
Record last verified: 2017-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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