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RCT of Paclitaxel DEB Compared to Standard PTA in Dialysis Fistula — APERTO  

Vascular Access Complication Clinical Trial

Official title:
A Randomized Trial of Aperto Paclitaxel Eluting Dilatation Catheter Compared to POBA in Dialysis Fistula

Clinical Trial Summary

A multicenter randomized clinical trial of paclitaxel drug-eluting balloon (DEB) versus standard percutaneous transluminal angioplasty (PTA) to reduce restenosis in 150 patients with haemodialysis access stenoses.

Clinical Trial Description

Prospective multicenter randomized (1:1) Investigator Sponsored Trial, in which 150 consecutive patients candidates for percutaneous intervention of haemodialysis access will be randomly assigned to one of two study arms:

1. Treatment Arm: paclitaxel drug-eluting balloon (DEB) dilatation using the APERTO-balloon

2. Control Arm: standard percutaneous transluminal angioplasty (PTA).

The aim is to evaluate the safety and efficacy of paclitaxel drug-eluting balloon (DEB) for the reduction of restenosis in haemodialysis shunts compared to standard percutaneous transluminal angioplasty (PTA). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02558153
Study type Interventional
Source Groene Hart Ziekenhuis
Contact
Status Completed
Phase N/A
Start date June 2015
Completion date July 3, 2019
View Details
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