A Phase 3 interventional study of Paclitaxel-releasing PTA balloon catheter and PTA balloon catheter in Arteriovenous Fistula Renal Dialysis Devices Obstruction, sponsored by Fundación Pública Andaluza Progreso y Salud. Completed at 4 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-22.
Sponsored by Fundación Pública Andaluza Progreso y Salud · Phase 3, Interventional, and Treatment
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.
Fundación Pública Andaluza Progreso y Salud is the lead sponsor of 29 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Treatment of renal dialysis arteriovenous fistula stenosis with paclitaxel-releasing percutaneous transluminal angioplastic (PTA) balloon catheter.
Device: Paclitaxel-releasing 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
Percentage of patients that do not need any revascularization proceeding during the following twelve months after catheter insertion.
Time frame: 12 months
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Fundación Pública Andaluza Progreso y Salud