Dialysis Access Dysfunction
Conditions
Keywords
dialysis fistula, cephalic arch stenosis, balloon angioplasty, drug eluting balloon
Brief summary
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
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.
Interventions
DRUGpaclitaxel (Cardionovum Legflow drug eluting balloon)
Elution of paclitaxel from inflated balloon catheter into vessel wall
DEVICEBalloon angioplasty (Bard Dorado)
Dilatation of cephalic arch venous stenosis by radial force applied by a balloon catheter
Sponsors
Shaare Zedek Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Restenosis rate | 6 months | Incidence of \>50% stenosis at the treatment site |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post intervention lesion patency | Up to 12 months | Interval between intervention and the time of the first subsequent intervention at the treatment site |
Countries
Israel
Outcome results
None listed