Study Stopped
Imbalance in the # graft infections between the tx's (graft vs. graft + wrap)
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
1 other identifier
interventional
222
1 country
30
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2008
Typical duration for not_applicable
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 15, 2009
CompletedFirst Posted
Study publicly available on registry
December 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedFebruary 11, 2013
February 1, 2013
2 years
December 15, 2009
February 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Nature and incidence of Adverse Events between treatment groups clinical difference in product-related adverse events
4 years
Study Arms (2)
Graft, Vascular Wrap
ACTIVE COMPARATORLifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)
Graft
PLACEBO COMPARATORLifespan® ePTFE Vascular Graft Only
Interventions
Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Subjects who withdrew or were withdrawn from study 012-VWAV06.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Ladenheim, Inc.
Fresno, California, 93710, United States
Centinela Hospital
Inglewood, California, 90301, United States
National Institute of Clinical Research
Los Angeles, California, 90017, United States
USC CVTI - Healthcare Consultation II
Los Angeles, California, 90033, United States
UCSD Medical Center
San Diego, California, 92109, United States
Southern California Permanente Medical Group
San Diego, California, 92120, United States
San Francisco VA Medical Center
San Francisco, California, 94121, United States
Florida Research Network, LLC
Gainsville, Florida, 32605, United States
Jacksonville Center for Clincal Research
Jacksonville, Florida, 32216, United States
Discovery Medical Research Group
Ocala, Florida, 34471, United States
Baptist Hospital
Pensacola, Florida, 32501, United States
University of South Florida- Research Foundation
Tampa, Florida, 33606, United States
Cardiothoracic and Vascular Surgery Associates
Macon, Georgia, 31208, United States
Renal Care Associates
Peoria, Illinois, 61603, United States
Southern Illinois University
Springfield, Illinois, 62702, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Washington County Hospital Association
Hagerstown, Maryland, 21740, United States
Michigan Vascular Research Center
Flint, Michigan, 48507, United States
Thoracic and Cardiovascular Healthcare Foundation
Lansing, Michigan, 48910, United States
Nephrology Associates P. C.
Flushing, New York, 11355, United States
St. Luke's Roosevelt Hospital Center
New York, New York, 10025, United States
BRANY - Montefiore Medical Center
The Bronx, New York, 10467, United States
Rex Healthcare
Raleigh, North Carolina, 27607, United States
Clinical Research of Winston-Salem, Inc.
Winston-Salem, North Carolina, 27103, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
University of Toledo
Toledo, Ohio, 43615, United States
Health First Medical Group
Fort Worth, Texas, 76135, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430, United States
Peripheral Vascular Associates
San Antonio, Texas, 78205, United States
The Wisconsin Heart Hospital
Wauwatosa, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rui Avelar, M.D.
Angiotech Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2009
First Posted
December 16, 2009
Study Start
March 1, 2008
Primary Completion
March 1, 2010
Study Completion
October 1, 2010
Last Updated
February 11, 2013
Record last verified: 2013-02