Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448708
Status:
TERMINATED
Last Update Posted:
2011-11-17
First Post:
2007-03-15
Brief Title:
Safety and Efficacy of Angiotech Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access
Sponsor:
Angiotech Pharmaceuticals
Organization:
Angiotech Pharmaceuticals
Study Overview
Official Title:
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
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to an imbalance in graft infections between groups
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
IDE Number G060250
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None