NCT02565953

Primary Patency in Post-angioplasty Dysfunctional Arteriovenous Fistula in Renal Dialysis: Paclitaxel-releasing PTA Balloon Catheter vs PTA Balloon

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Fundación Pública Andaluza Progreso y Salud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arteriovenous Fistula Renal Dialysis Devices Obstruction

Interventions

Type	Name	Description
DEVICE	Paclitaxel-releasing PTA balloon catheter
DEVICE	PTA balloon catheter

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2015-10-01
• Last updated: 2019-02-22

Locations

4 sites across 1 country: Spain