NCT01174472

Drug Eluting Balloon Angioplasty for Dialysis Access Treatment

Drug Eluting Versus Conventional Balloon Angioplasty for the Treatment of Failing Dialysis Access. A Prospective Randomized Single-Center Trial.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Patras · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to compare the feasibility and the effectiveness, by means of immediate and long-term results, of drug eluting balloon (DEB) versus conventional balloon angioplasty for the treatment of failing dialysis access.

Detailed description

In total 40 patients already diagnosed with hemodynamically significant stenosis of the dialysis AVF or AVG (including venous outflow lesions), programmed to undergo percutaneous transluminal angioplasty by our department, will sign informed consent and will be randomized to either receive DEB (Paclitaxel eluting balloon), or conventional balloon therapy. The protocol includes the description of patient's demographics (age, gender,dialysis access details, risk factors) and procedural details, as well as immediate results and long-term follow up.

Conditions

• Dialysis
• Angioplasty

Interventions

Type	Name	Description
DEVICE	Percutaneous Transluminal Angioplasty (PTA)	Angioplasty performed with the use of the novel paclitaxel eluting balloons
DEVICE	Percutaneous Transluminal Angioplasty (PTA)	Angioplasty performed with the use of conventional angioplasty balloons

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-12-01
• Completion: 2012-01-01
• First posted: 2010-08-03
• Last updated: 2012-01-23

Locations

1 site across 1 country: Greece