Drug Eluting Balloon Angioplasty for Dialysis Access Treatment

Phase 2

Completed

• Conditions: Dialysis; Angioplasty
• Interventions: Device: Percutaneous Transluminal Angioplasty (PTA)

• Registration Number: NCT01174472
• Lead Sponsor: University of Patras

Brief 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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-07-21
• Study First Submitted QC: 2010-08-02
• Study First Posted: 2010-08-03
• Primary Completion: 2010-12
• Status Verified: 2012-01
• Study Completion: 2012-01
• Last Update Submitted: 2012-01-20
• Last Update Posted: 2012-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Balloon Angioplasty (COBA)	Percutaneous Transluminal Angioplasty (PTA)	Patients with lesions treated with conventional balloon angioplasty
Drug Eluting Balloon Angioplasty (DEB)	Percutaneous Transluminal Angioplasty (PTA)	Patients with lesions treated with Drug Balloon Angioplasty

Primary Outcome Measures

Name	Time	Method
Technical success	1 minute after the final balloon angioplasty	Residual stenosis of the treated lesion less than 30%, without any hemodynamicaly significant dissection (Type C)after the final angiography
Primary patency	1 year	Angiographic visualization of a lesion with \<50% restenosis and no need for any additional repeat interventional procedure within the previously treated lesion, due to failing access.

Secondary Outcome Measures

Name	Time	Method
Secondary patency	1 year	Angiographicaly proven patency (\<50% restenosis and no need for any additional repeat interventional procedure within the previously treated lesion, due to failing access)of the treated lesion following one re-intervention procedure of any kind.
Target lesion re-intervention (TLR)-free interval	1 year	The time interval without any additional recanalization procedure within the area of the treated lesion, because of angiographic or/and clinical deterioration
Major complications rates	Periprocedural and up to 1 year	Classified according to published international guidelines and reporting standards
Minor complications rates	Periprocedural and up to 1 year follow-up	Classified according to published international guidelines and reporting standards

Trial Locations

Locations (1)

Patras University Hospital, Department of Radiology, Angiography Suite; 🇬🇷 Rion, Achaias, Greece