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

This study has been terminated.
(Imbalance in the # graft infections between the tx's (graft vs. graft + wrap))
Sponsor:
Information provided by (Responsible Party):
Angiotech Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01033357
First received: December 15, 2009
Last updated: February 7, 2013
Last verified: February 2013

December 15, 2009
February 7, 2013
March 2008
March 2010   (final data collection date for primary outcome measure)
Nature and incidence of Adverse Events between treatment groups clinical difference in product-related adverse events [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Nature and incidence of AEs between treatment groups clinical difference in product-related adverse events [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01033357 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • End Stage Renal Failure on Dialysis
  • Hyperplasia
  • Device: Graft, Vascular Wrap
    Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)
    Other Name: Vascular Wrap
  • Device: Lifespan® ePTFE Vascular Graft Only
    Vascular Graft only
  • Active Comparator: Graft, Vascular Wrap
    Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)
    Intervention: Device: Graft, Vascular Wrap
  • Placebo Comparator: Graft
    Lifespan® ePTFE Vascular Graft Only
    Intervention: Device: Lifespan® ePTFE Vascular Graft Only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
222
October 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria: To be considered for enrollment, subjects must:

  • have been randomized in protocol 012-VWAV06;
  • have signed and dated an IRB-approved written informed consent to participate in 012-VWAV06 as well as this study;
  • be willing to comply with all aspects of the evaluation schedule over a period of 60 months post device insertion;
  • allow representatives of the sponsor, designated Clinical Research Organization (CRO), Institutional Review Board (IRB), the Ethics Committee, and U.S. Food and Drug Administration (FDA) to review his/her relevant medical records.

Exclusion Criteria:

  • Subjects who withdrew or were withdrawn from study 012-VWAV06.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01033357
014-VWAV07
No
Angiotech Pharmaceuticals
Angiotech Pharmaceuticals
Not Provided
Study Chair: Rui Avelar, M.D. Angiotech Pharmaceuticals
Angiotech Pharmaceuticals
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP