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

Purpose

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	Intervention
End Stage Renal Failure on Dialysis Hyperplasia	Device: Graft, Vascular Wrap Device: Lifespan® ePTFE Vascular Graft Only

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by Angiotech Pharmaceuticals:

Primary Outcome Measures:

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 ]

Enrollment:	222
Study Start Date:	March 2008
Study Completion Date:	October 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033357

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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

Investigators

Study Chair:

Rui Avelar, M.D.

Angiotech Pharmaceuticals

More Information

No publications provided

Responsible Party:	Angiotech Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01033357 History of Changes
Other Study ID Numbers:	014-VWAV07
Study First Received:	December 15, 2009
Last Updated:	February 7, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Angiotech Pharmaceuticals:

dialysis
hemodialysis
neointimal hyperplasia

Additional relevant MeSH terms:

Hyperplasia
Kidney Failure, Chronic
Renal Insufficiency
Pathologic Processes
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Paclitaxel

Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013