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

End Stage Renal Failure on Dialysis Clinical Trial

Official title:
A Long Term Safety Study of the Vascular Wrap(TM) Paclitaxel-Eluting Mesh After Surgical Implantation With the Lifespan® Graft in the Upper Extremity for Hemodialysis Vascular Access

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01033357
Study type Interventional
Source Angiotech Pharmaceuticals
Contact
Status Terminated
Phase N/A
Start date March 2008
Completion date October 2010
View Details
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