NCT01033357

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Angiotech Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• End Stage Renal Failure on Dialysis
• Hyperplasia

Interventions

Type	Name	Description
DEVICE	Graft, Vascular Wrap	Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)
DEVICE	Lifespan® ePTFE Vascular Graft Only	Vascular Graft only

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-03-01
• Completion: 2010-10-01
• First posted: 2009-12-16
• Last updated: 2013-02-11

Locations

30 sites across 1 country: United States