Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-29 @ 3:12 PM
Study NCT ID:
NCT01033357
Status:
TERMINATED
Last Update Posted:
2013-02-11
First Post:
2009-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of the Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access
Sponsor:
Angiotech Pharmaceuticals
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Imbalance in the # graft infections between the tx's (graft vs. graft + wrap)
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: