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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01033357
Recruitment Status : Terminated (Imbalance in the # graft infections between the tx's (graft vs. graft + wrap))
First Posted : December 16, 2009
Last Update Posted : February 11, 2013
Sponsor:
Information provided by (Responsible Party):
Angiotech Pharmaceuticals

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).

Condition or disease Intervention/treatment
End Stage Renal Failure on Dialysis Hyperplasia Device: Graft, Vascular Wrap Device: Lifespan® ePTFE Vascular Graft Only

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : March 2008
Primary Completion Date : March 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
Drug Information available for: Paclitaxel
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Graft, Vascular Wrap
Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)
Device: Graft, Vascular Wrap
Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)
Other Name: Vascular Wrap
Placebo Comparator: Graft
Lifespan® ePTFE Vascular Graft Only
Device: Lifespan® ePTFE Vascular Graft Only
Vascular Graft only



Primary Outcome Measures :
  1. Nature and incidence of Adverse Events between treatment groups clinical difference in product-related adverse events [ Time Frame: 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033357


  Show 30 Study Locations
Sponsors and Collaborators
Angiotech Pharmaceuticals
Investigators
Study Chair: Rui Avelar, M.D. Angiotech Pharmaceuticals

Responsible Party: Angiotech Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01033357     History of Changes
Other Study ID Numbers: 014-VWAV07
First Posted: December 16, 2009    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: February 2013

Keywords provided by Angiotech Pharmaceuticals:
dialysis
hemodialysis
neointimal hyperplasia

Additional relevant MeSH terms:
Hyperplasia
Renal Insufficiency
Kidney Failure, Chronic
Pathologic Processes
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action