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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Angioplasty performed with the use of the novel paclitaxel eluting balloons
Angioplasty performed with the use of conventional angioplasty balloons
Patras University Hospital, Department of Radiology, Angiography Suite
Rio, Achaias, Greece
Technical success
Residual stenosis of the treated lesion less than 30%, without any hemodynamicaly significant dissection (Type C)after the final angiography
Time frame: 1 minute after the final balloon angioplasty
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.
Time frame: 1 year
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.
Time frame: 1 year
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
Time frame: 1 year
Major complications rates
Classified according to published international guidelines and reporting standards
Time frame: Periprocedural and up to 1 year
Minor complications rates
Classified according to published international guidelines and reporting standards
Time frame: Periprocedural and up to 1 year follow-up
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