Primary Patency in Post-angioplasty Dysfunctional Arteriovenous Fistula in Renal Dialysis: Paclitaxel-releasing PTA Balloon Catheter vs PTA Balloon
FISBAL
1 other identifier
interventional
134
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2015
Typical duration for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2015
CompletedFirst Posted
Study publicly available on registry
October 1, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedFebruary 22, 2019
March 1, 2017
3 years
September 30, 2015
February 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Paclitaxel-releasing PTA balloon catheter
EXPERIMENTALTreatment of renal dialysis arteriovenous fistula stenosis with paclitaxel-releasing percutaneous transluminal angioplastic (PTA) balloon catheter.
PTA Balloon catheter
ACTIVE COMPARATORTreatment of renal dialysis arteriovenous fistula stenosis with percutaneous transluminal angioplastic (PTA) balloon catheter.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2015
First Posted
October 1, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
February 22, 2019
Record last verified: 2017-03