Drug Eluting Balloon Angioplasty for Recurrent Cephalic Arch Stenosis in Dialysis Fistulas

Study Overview
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Brief Summary
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This study is designed to compare the safety and efficacy of paclitaxel-eluting balloon (DEB) versus conventional percutaneous transluminal angioplasty (PTA) for the treatment of hemodynamically significant recurrent cephalic arch stenosis in brachial cephalic fistulas in hemodialysis patients.

Detailed Description
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The cephalic vein constitutes the major outflow conduit for radial- cephalic autogenous accesses and is the sole outflow conduit for brachial- cephalic autogenous accesses. The portion of the cephalic vein that becomes perpendicular in the region of the deltopectoral groove before its confluence with the axillary or subclavian vein,the cephalic arch, is prone to the development of hemodynamically significant stenosis which is usually treated with balloon angioplasty. Unfortunately restenosis due to angioplasty induced intimal hyperplasia is common and periodic repeated angioplasty is necessary to maintain patency. Paclitaxel is a mitotic inhibitor used in cancer chemotherapy which is used as an antiproliferative agent for the prevention of restenosis (recurrent narrowing) of blood vessels after balloon angioplasty caused by excessive intimal proliferation. It is locally delivered to the wall of the blood vessel during the dilatation using a paclitaxel eluting balloon. Initial trials with these balloons have shown promising results in peripheral arteries and early encouraging results in dialysis access.

Official Title
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Prospective Randomized Trial Comparing Drug Eluting Balloon Versus Conventional Balloon Angioplasty for Recurrent Cephalic Arch Stenosis in Dialysis Fistulas.

Conditions
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Dialysis Access Dysfunction

Intervention / Treatment
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* Drug: paclitaxel (Cardionovum Legflow drug eluting balloon)
* Device: Balloon angioplasty (Bard Dorado)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Upper limb dialysis access fistula Angiographically demonstrated cephalic arch stenosis >50% within 6 months of last angioplasty using a non drug eluting balloon Clinical evidence of hemodynamically significant stenosis: strong pulse and weak thrill on physical exam, prolonged bleeding from puncture sites, raised Kt/V, raised dialysis venous pressure Exclusion Criteria: Contrast allergy Unable to give informed consent Cephalic arch stent or stent graft Life expectancy less then 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard balloon angioplasty<br>Dilatation of stenosis with standard non drug eluting balloon catheter | Device: Balloon angioplasty (Bard Dorado)<br>* Dilatation of cephalic arch venous stenosis by radial force applied by a balloon catheter<br>* Other names: Bard Dorado balloon catheter;|
| Experimental: Drug eluting balloon angioplasty<br>Dilatation of stenosis with paclitaxel eluting balloon catheter | Drug: paclitaxel (Cardionovum Legflow drug eluting balloon)<br>* Elution of paclitaxel from inflated balloon catheter into vessel wall<br>* Other names: Cardionovum Legflow drug eluting balloon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restenosis rate | Incidence of >50% stenosis at the treatment site | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post intervention lesion patency | Interval between intervention and the time of the first subsequent intervention at the treatment site | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dialysis fistula, cephalic arch stenosis, balloon angioplasty, drug eluting balloon