Safety Study of the Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access

The purpose of this study is to determine whether the long term use of the experimental Vascular Wrap(TM) Paclitaxel-Eluting Mesh is safe in the treatment of subjects needing hemodialysis access (via an expanded polytetrafluoroethylene (ePTFE) graft).

The primary objective of this study is to determine long term safety of the Lifespan® ePTFE Vascular Graft and Vascular Wrap(TM) Paclitaxel-Eluting Mesh in comparison to the Lifespan® graft alone.

• End Stage Renal Failure on Dialysis
• Hyperplasia

• Device: Graft, Vascular Wrap
  Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)
  Other Name: Vascular Wrap
• Device: Lifespan® ePTFE Vascular Graft Only
  Vascular Graft only

• Active Comparator: Graft, Vascular Wrap
  Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)
  Intervention: Device: Graft, Vascular Wrap
• Placebo Comparator: Graft
  Lifespan® ePTFE Vascular Graft Only
  Intervention: Device: Lifespan® ePTFE Vascular Graft Only

Inclusion Criteria: To be considered for enrollment, subjects must:

• have been randomized in protocol 012-VWAV06;
• have signed and dated an IRB-approved written informed consent to participate in 012-VWAV06 as well as this study;
• be willing to comply with all aspects of the evaluation schedule over a period of 60 months post device insertion;
• allow representatives of the sponsor, designated Clinical Research Organization (CRO), Institutional Review Board (IRB), the Ethics Committee, and U.S. Food and Drug Administration (FDA) to review his/her relevant medical records.

Exclusion Criteria:

• Subjects who withdrew or were withdrawn from study 012-VWAV06.