Drug Eluting Balloon Angioplasty for Dialysis Access Treatment

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dialysis, Angioplasty

Intervention / Treatment
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* Device: Percutaneous Transluminal Angioplasty (PTA)
* Device: Percutaneous Transluminal Angioplasty (PTA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Balloon Angioplasty (COBA)<br>Patients with lesions treated with conventional balloon angioplasty | Device: Percutaneous Transluminal Angioplasty (PTA)<br>* Angioplasty performed with the use of conventional angioplasty balloons<br>* Other names: Conquest PTA Balloon Dilatation Catheter;|
| Experimental: Drug Eluting Balloon Angioplasty (DEB)<br>Patients with lesions treated with Drug Balloon Angioplasty | Device: Percutaneous Transluminal Angioplasty (PTA)<br>* Angioplasty performed with the use of the novel paclitaxel eluting balloons<br>* Other names: IN.PACT ADMIRAL, Paclitaxel eluting dilatation PTA catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Major complications rates | Classified according to published international guidelines and reporting standards | Periprocedural and up to 1 year | 
| Minor complications rates | Classified according to published international guidelines and reporting standards | Periprocedural and up to 1 year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis access, angioplasty, drug eluting balloon