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Drug Eluting Balloon for Prevention of Hemodialysis Access Restenosis — DEB  

Arteriovenous Graft Clinical Trial

Official title:
Evaluation of Drug Eluting Balloon for the Prevention of Hemodialysis Access Restenosis: A Prospective Randomized Trial (DEB Study)

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of paclitaxel-coated balloon catheter to prevent restenosis after PTA (percutaneous transluminal angioplasty) of hemodialysis access (HA) in comparison with the uncoated PTA balloon catheter.

Clinical Trial Description

In Canada, there are over 20,000 patients with chronic end-stage renal disease (ESRD)on long-term hemodialysis and the number is increasing rapidly.The creation of hemodialysis access (HA) (also called "lifeline" for dialysis patients) has become the most common type of vascular surgery. These HA are frequently complicated by dysfunction after their creation mainly due to neointimal hyperplastic stenosis (> 60% at one year). PTA is an established cornerstone method of treating stenotic lesions because of its minimally invasive percutaneous nature and widespread availability.Although PTA has a high initial success rate,narrowing will often recur in 2-3 months hence requiring further interventions. There are currently no durable therapies for the prevention or treatment of HA dysfunction restenosis after PTA. Recently drug eluting balloon (DEB) with paclitaxel have repeatedly demonstrated their effectiveness to prevent restenosis due to intimal proliferation in the coronary and peripheral arterial systems. The investigators believe that the DEB with paclitaxel will significantly decrease the HA restenosis rate at the treated site and therefore will improve the management of HA failures. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01928498
Study type Interventional
Source Centre hospitalier de l'Université de Montréal (CHUM)
Contact
Status Completed
Phase N/A
Start date October 2013
Completion date August 27, 2020
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