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. 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
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 Phase
End Stage Renal Failure on Dialysis Hyperplasia Device: Graft, Vascular Wrap Device: Lifespan® ePTFE Vascular Graft Only Not Applicable

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
Actual Primary Completion Date : March 2010
Actual 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

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 identifier (NCT number): NCT01033357

  Hide Study Locations
United States, California
Ladenheim, Inc.
Fresno, California, United States, 93710
Centinela Hospital
Inglewood, California, United States, 90301
National Institute of Clinical Research
Los Angeles, California, United States, 90017
USC CVTI - Healthcare Consultation II
Los Angeles, California, United States, 90033
UCSD Medical Center
San Diego, California, United States, 92109
Southern California Permanente Medical Group
San Diego, California, United States, 92120
San Francisco VA Medical Center
San Francisco, California, United States, 94121
United States, Florida
Florida Research Network, LLC
Gainsville, Florida, United States, 32605
Jacksonville Center for Clincal Research
Jacksonville, Florida, United States, 32216
Discovery Medical Research Group
Ocala, Florida, United States, 34471
Baptist Hospital
Pensacola, Florida, United States, 32501
University of South Florida- Research Foundation
Tampa, Florida, United States, 33606
United States, Georgia
Cardiothoracic and Vascular Surgery Associates
Macon, Georgia, United States, 31208
United States, Illinois
Renal Care Associates
Peoria, Illinois, United States, 61603
Southern Illinois University
Springfield, Illinois, United States, 62702
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Maryland
Washington County Hospital Association
Hagerstown, Maryland, United States, 21740
United States, Michigan
Michigan Vascular Research Center
Flint, Michigan, United States, 48507
Thoracic and Cardiovascular Healthcare Foundation
Lansing, Michigan, United States, 48910
United States, New York
BRANY - Montefiore Medical Center
Bronx, New York, United States, 10467
Nephrology Associates P. C.
Flushing, New York, United States, 11355
St. Luke's Roosevelt Hospital Center
New York, New York, United States, 10025
United States, North Carolina
Rex Healthcare
Raleigh, North Carolina, United States, 27607
Clinical Research of Winston-Salem, Inc.
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
University of Toledo
Toledo, Ohio, United States, 43615
United States, Texas
Health First Medical Group
Fort Worth, Texas, United States, 76135
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Peripheral Vascular Associates
San Antonio, Texas, United States, 78205
United States, Wisconsin
The Wisconsin Heart Hospital
Wauwatosa, Wisconsin, United States, 53226
Sponsors and Collaborators
Angiotech Pharmaceuticals
Study Chair: Rui Avelar, M.D. Angiotech Pharmaceuticals

Responsible Party: Angiotech Pharmaceuticals 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:
neointimal hyperplasia

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