Clinical trial NCT01174472: Drug Eluting Balloon Angioplasty for Dialysis Access Treatment
Official title: Drug Eluting Versus Conventional Balloon Angioplasty for the Treatment of Failing Dialysis Access. A Prospective Randomized Single-Center Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dialysis
Angioplasty
Keywords: Dialysis access
angioplasty
drug eluting balloon
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2010-08-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Technical success
timeFrame: 1 minute after the final balloon angioplasty
measure: Primary patency
timeFrame: 1 year
Secondary outcomes:
measure: Secondary patency
timeFrame: 1 year
measure: Target lesion re-intervention (TLR)-free interval
timeFrame: 1 year
measure: Major complications rates
timeFrame: Periprocedural and up to 1 year
measure: Minor complications rates
timeFrame: Periprocedural and up to 1 year follow-up
Other outcomes:
Locations:
city: Rion
country: Greece
facility: Patras University Hospital, Department of Radiology, Angiography Suite
state: Achaias
Study officials:
affiliation: University Hospital of Patras
name: Dimitrios Siablis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kitrou PM, Katsanos K, Spiliopoulos S, Karnabatidis D, Siablis D. Drug-eluting versus plain balloon angioplasty for the treatment of failing dialysis access: final results and cost-effectiveness analysis from a prospective randomized controlled trial (NCT01174472). Eur J Radiol. 2015 Mar;84(3):418-423. doi: 10.1016/j.ejrad.2014.11.037. Epub 2014 Dec 15.
citation: Katsanos K, Karnabatidis D, Kitrou P, Spiliopoulos S, Christeas N, Siablis D. Paclitaxel-coated balloon angioplasty vs. plain balloon dilation for the treatment of failing dialysis access: 6-month interim results from a prospective randomized controlled trial. J Endovasc Ther. 2012 Apr;19(2):263-72. doi: 10.1583/11-3690.1.