Dialysis Access Dysfunction Clinical Trial
Official title:
Prospective Randomized Trial Comparing Drug Eluting Balloon Versus Conventional Balloon Angioplasty for Recurrent Cephalic Arch Stenosis in Dialysis Fistulas.
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.
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.
;