Drug Eluting Balloon Angioplasty for Dialysis Access Treatment

University of Patras

Status and phase: Completed; Phase 3; Phase 2

Conditions: Dialysis; Angioplasty

Treatments: Device: Percutaneous Transluminal Angioplasty (PTA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01174472

9462/14-4-2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Angiographic and clinical diagnosis of dysfunctional dialysis access due to one or more stenotic lesions.
• Patients with AVF or AVG
• Fistula or graft or vessel diameter ranging from 3 mm up to 12 mm

Exclusion criteria

• Fistula or graft or vessel diameter < 3 mm and > 12 mm
• History of severe allergic reaction to contrast media
• Intolerance to aspirin and/or clopidogrel
• Systemic coagulopathy or hypercoagulation disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Conventional Balloon Angioplasty (COBA)

Active Comparator group

Description:

Patients with lesions treated with conventional balloon angioplasty

Treatment:

Device: Percutaneous Transluminal Angioplasty (PTA)

Device: Percutaneous Transluminal Angioplasty (PTA)

Drug Eluting Balloon Angioplasty (DEB)

Experimental group

Description:

Patients with lesions treated with Drug Balloon Angioplasty

Treatment:

Device: Percutaneous Transluminal Angioplasty (PTA)

Device: Percutaneous Transluminal Angioplasty (PTA)