Clinical Trials at Englewood Hospital: Surgery
EHMC IRB Study #:E-12-468
Dr. Kurt Wengerter
Karen Hessler, RN
The Use of Intravascular Paclitaxel for the Treatment of Upper-Arm Arteriovenous Access Fistula Stenosis: A Randomized Study (PaciFIST-1)
Hemodialysis patients who are at least 18 years old and have an upper-arm cephalic or basilica vein fistula access with stenosis of greater than or equal to 50%.
To evaluate the safety and effectiveness of the use of intravascular paclitaxel for the treatment of arteriovenous dialysis access fistula stenosis.
Standard treatment of all stenotic lesions will be carried out in the usual fashion. Once the standard treatment is completed, the operating surgeon will be informed of the patient allocation: treatment (paclitaxel) or control. For subjects assigned to treatment, the whole fistula vein outflow segment of the fistula will be treated with paclitaxel.The TAPAS infusion catheter will be used for all paclitaxel dose administrations. The instructions for use (IFU) for the TAPAS catheter will be followed. The volume of drugto be administered will be calculated by the length of the lesion and size of vessel to be treated. After the full outflow vein segment is treated the fistulogram is completed in the standard fashion. Prior to removal of the sheath a final angiographic study of all areas treated is performed to document patency and lesion appearance.For the control group, a sham treatment period of 10 minutes is allowed to elapse followed by the performance of a final completion angiogram, any additional lesions identified with this study are then treated appropriately following standard technique.