Safety and Efficacy of Angiotech Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access
|ClinicalTrials.gov Identifier: NCT00448708|
Recruitment Status : Terminated (Due to an imbalance in graft infections between groups.)
First Posted : March 19, 2007
Results First Posted : November 17, 2011
Last Update Posted : November 17, 2011
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
|Condition or disease||Intervention/treatment|
|Kidney Diseases ESRD||Device: Vascular Wrap Paclitaxel-Eluting Mesh Device: Lifespan® ePTFE Vascular Graft|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||222 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||March 2007|
|Primary Completion Date :||April 2009|
|Study Completion Date :||April 2009|
Experimental: Vascular Wrap and Graft
Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh: The Lifespan® ePTFE Vascular Graft is implanted as an arteriovenous graft in an upper extremity to provide a hemodialysis access. The Vascular WrapTM Paclitaxel-Eluting Mesh is positioned on the vein and placed around the venous anastomosis to include both the toe and the heel of the anastomosis, and is sutured in place.
Device: Vascular Wrap Paclitaxel-Eluting Mesh
0.9 µg/mm^2 paclitaxel
Other Names:Device: Lifespan® ePTFE Vascular Graft
No Intervention: Lifespan® ePTFE Vascular Graft
Lifespan® ePTFE Vascular Graft Only: The Lifespan® ePTFE Vascular Graft is implanted as an arteriovenous graft in an upper extremity to provide a hemodialysis access.
Device: Lifespan® ePTFE Vascular Graft
- Time-to-loss of Target Site Primary Patency [ Time Frame: 1 year ]Subjects had primary patency at the target site from graft placement until an intervention on the target site occurred. The duration between graft implantation and graft abandonment due to loss of patency at the target site was the "time-to-loss of primary patency." Note: The study was halted early and therefore became underpowered to analyze efficacy as detailed in the protocol.
- Adverse Events [ Time Frame: 1 year ]adverse events with at least 5% incidence, reported as number of subjects experiencing the event (rather than total number of events). Adverse events were collected via subject querying at each visit and telephone contact, and by medical record review.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448708
Show 33 Study Locations
|Study Chair:||Rui Avelar, MD||Angiotech Pharmaceuticals|