Drug Eluting Balloon Angioplasty for Dialysis Access Treatment

Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174472
• Other study ID #: 9462/14-4-2010
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 21, 2010
• Last updated: January 20, 2012
• Start date: March 2010
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: University of Patras
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angioplasty
• Dialysis

Intervention

Device:
• Percutaneous Transluminal Angioplasty (PTA)
Angioplasty performed with the use of the novel paclitaxel eluting balloons
• Percutaneous Transluminal Angioplasty (PTA)
Angioplasty performed with the use of conventional angioplasty balloons

Locations

Country	Name	City	State
Greece	Patras University Hospital, Department of Radiology, Angiography Suite	Rion	Achaias

Sponsors (1)

Lead Sponsor	Collaborator
University of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success	Residual stenosis of the treated lesion less than 30%, without any hemodynamicaly significant dissection (Type C)after the final angiography	1 minute after the final balloon angioplasty	Yes
Primary	Primary patency	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.	1 year	No
Secondary	Secondary patency	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.	1 year	No
Secondary	Target lesion re-intervention (TLR)-free interval	The time interval without any additional recanalization procedure within the area of the treated lesion, because of angiographic or/and clinical deterioration	1 year	No
Secondary	Major complications rates	Classified according to published international guidelines and reporting standards	Periprocedural and up to 1 year	Yes
Secondary	Minor complications rates	Classified according to published international guidelines and reporting standards	Periprocedural and up to 1 year follow-up	Yes