Safety and Efficacy of Angiotech Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access
NCT ID: NCT00448708
Last Updated: 2011-11-17
Study Results
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View full resultsBasic Information
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TERMINATED
NA
222 participants
INTERVENTIONAL
2007-03-31
2009-04-30
Brief Summary
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IDE Number: G060250
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Vascular Wrap Paclitaxel-Eluting Mesh
0.9 µg/mm\^2 paclitaxel
Lifespan® ePTFE Vascular Graft
vascular graft
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.
Lifespan® ePTFE Vascular Graft
vascular graft
Interventions
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Vascular Wrap Paclitaxel-Eluting Mesh
0.9 µg/mm\^2 paclitaxel
Lifespan® ePTFE Vascular Graft
vascular graft
Lifespan® ePTFE Vascular Graft
vascular graft
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. if female of childbearing potential, provide evidence of a negative pregnancy test within 3 days prior to graft placement (Day -3 to Day 0);
3. be a candidate for a new end-to-side arteriovenous anastomosis graft placed in the upper extremity;
4. have an outflow vein of greater than or equal to 3 mm in diameter;
5. be able to effectively communicate with study personnel;
6. be considered by the physician to be available for subsequent visits;
7. be willing to comply with all aspects of the treatment and evaluation schedule over a 52 week duration;
8. allow representatives of the sponsor, designated CRO, Institutional Review Board (IRB), the Ethics Committee, and U.S. Food and Drug Administration (FDA) to review his/her relevant medical records;
9. sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures;
10. must agree to participate in protocol 014-VWAV07, a safety study to run consecutively for an additional 4 years or until Post-Market Approval (PMA), whichever is longer; and
11. have the Lifespan® ePTFE Vascular Graft successfully implanted.
Exclusion Criteria
2. male of childbearing potential, who does not agree to remain abstinent or to use contraception to prevent fathering a child during the course of the study. Non-childbearing potential is defined as vasectomy or bilateral orchiectomy;
3. a central venous stenosis on the ipsilateral side is documented;
4. a hypercoagulable state is documented;
5. life expectancy is less than one year;
6. an organ transplant is expected within 6 months of test or control product (study products) placement;
7. hypersensitivity to any component of the study products or procedural materials or medications is known;
8. concurrently involved in another investigational study;
9. a study product being investigated by others has been received within 30 days prior to randomization in this trial;
10. the study product being studied in this trial has previously been received;
11. uncontrolled hypertension with systolic BP \>200mmHg or diastolic BP \>115mmHg is present at screening;
12. currently receiving chemotherapy or radiation therapy; or
13. placement of a new end-to-end arteriovenous anastomosis graft is required.
18 Years
ALL
No
Sponsors
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Angiotech Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Rui Avelar, MD
Role: STUDY_CHAIR
Angiotech Pharmaceuticals
Locations
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Clinical Research Center
Birmingham, Alabama, United States
Ladenheim, Inc.
Fresno, California, United States
Centinela Hospital
Inglewood, California, United States
National Institute of Clinical Research
Los Angeles, California, United States
USC CVTI - Healthcare Consultation II
Los Angeles, California, United States
UCSD Medical Center
San Diego, California, United States
Southern California Permanente Medical Group
San Diego, California, United States
San Francisco VA Medical Center
San Francisco, California, United States
Florida Research Network, LLC
Gainsville, Florida, United States
Jacksonville Center for Clincal Research
Jacksonville, Florida, United States
Discovery Medical Research Group
Ocala, Florida, United States
Baptist Cancer Institute
Pensacola, Florida, United States
Southeastern Urological Center, P.A
Tallahassee, Florida, United States
University of South Florida- Research Foundation
Tampa, Florida, United States
Cardiothoracic and Vascular Surgery Associates
Macon, Georgia, United States
Renal Care Associates
Peoria, Illinois, United States
Southern Illinois University
Springfield, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Washington County Hospital Association
Hagerstown, Maryland, United States
Michigan Vascular Research Center
Flint, Michigan, United States
Thoracic and Cardiovascular Healthcare Foundation
Lansing, Michigan, United States
Nephrology Associates P. C.
Flushing, New York, United States
St. Luke's Roosevelt Hospital Center
New York, New York, United States
Biomedical Research Alliance of New York
The Bronx, New York, United States
BRANY - Montefiore Medical Center
The Bronx, New York, United States
Rex Hospital
Raleigh, North Carolina, United States
Clinical Research of Winston-Salem, Inc.
Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
University of Toledo
Toledo, Ohio, United States
Health First Medical Group
Fort Worth, Texas, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, United States
Peripheral Vascular Associates
San Antonio, Texas, United States
The Wisconsin Heart Hospital
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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012-VWAV06
Identifier Type: -
Identifier Source: org_study_id