NCT00448708

Safety and Efficacy of Angiotech Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access

Trial to Assess the Effectiveness of Maintaining Patency and Safety of the Vascular Wrap Paclitaxel-Eluting Mesh After Surgical Implantation With the Lifespan® ePTFE Vascular 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

This is a multi-center clinical study in subjects requiring arteriovenous grafts in the upper extremity for hemodialysis access. All subjects will provide informed consent before undergoing any study procedures. The study will consist of multiple subject visits and telephone contacts during the 52 week study period. During the study period subjects must also maintain an appropriate hemodialysis schedule. IDE Number: G060250

Conditions

• Kidney Diseases
• ESRD

Interventions

Type	Name	Description
DEVICE	Vascular Wrap Paclitaxel-Eluting Mesh	0.9 µg/mm\^2 paclitaxel
DEVICE	Lifespan® ePTFE Vascular Graft	vascular graft
DEVICE	Lifespan® ePTFE Vascular Graft	vascular graft

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2007-03-19
• Last updated: 2011-11-17
• Results posted: 2011-11-17

Locations

33 sites across 1 country: United States