Paclitaxel for the Treatment of Distal Radial Artery Arteriovenous Access Fistula Stenosis (PaciFIST-2)

The objective of this study is to evaluate the safety and effectiveness of the use of intravascular paclitaxel, in addition to standard therapy, for the treatment of arteriovenous dialysis access fistula stenosis. A fistulogram will be performed in standard fashion. The diagnostic component will include evaluation of the inflow artery, arterial anastomosis and full length of the fistula vein or graft, plus venous return up to the heart. The location, vessel size, lesion diameter and percent stenosis for each lesion will be recorded. Enrollment and randomization will occur at this point. All patients will then receive standard therapy for their stenosis. This will include intravenous heparin administered in a standard dose of 70 units/kg. Lesions that respond poorly to angioplasty (\>30% residual stenosis after angioplasty treatment with 2 inflations) will be stented. Stent selection will be based on clinical setting. Initial stent treatment will utilize an uncovered nitinol stent. Treatment of in-stent restenosis will include initial balloon angioplasty, and use of a covered stent (Viabahn, GORE, or Fluency, Bard). Documentation of location and type of treatment for each lesion treated will be recorded. Once standard treatment is completed, the operating surgeon will be informed of the results of randomization: treatment (paclitaxel) or control. For subjects assigned to treatment, the whole fistula vein outflow segment of the fistula will be treated with paclitaxel. The full length of the radial artery from 1 cm of its origin to fistula anatomosis will be treated with paclitaxel. In addition the anastomosis and first 4 cm of the fistula vein will be treated. Paclitaxel solution treatment of each lesion encountered will be attempted until the 20 mg Paclitaxel dose limit is met. The volume administered will depend on the diameter and length of the vessels treated. Maximization of the length of vessel and lesions treated will be undertaken when there are more lesio