NCT02558153

RCT of Paclitaxel DEB Compared to Standard PTA in Dialysis Fistula

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Groene Hart Ziekenhuis · Academic / Other
• Sex: All
• Age: 19 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Complication of Hemodialysis
• Vascular Access Complication

Interventions

Type	Name	Description
DEVICE	DEB, drug eluting balloon	Percutaneous angioplasty performed with a DEB - drug eluting balloon
DEVICE	standard PTA	Percutaneous angioplasty performed with a standard balloon

Timeline

• Start date: 2015-06-01
• Primary completion: 2019-07-03
• Completion: 2019-07-03
• First posted: 2015-09-23
• Last updated: 2020-05-05

Locations

10 sites across 2 countries: Belgium, Netherlands