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
|Condition or disease||Intervention/treatment||Phase|
|Arteriovenous Fistula Renal Dialysis Devices Obstruction||Device: Paclitaxel-releasing PTA balloon catheter Device: PTA balloon catheter||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||134 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||October 2018|
|Actual Study Completion Date :||October 2018|
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
- 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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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565953
|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|