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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

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.

Detailed Summary:
Sponsor: Fundación Pública Andaluza Progreso y Salud

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Dates:
Date Received: September 30, 2015
Date Started: October 2015
Date Completion: June 2017
Last Updated: February 4, 2016
Last Verified: February 2016