Study Stopped
Due to an imbalance in graft infections between groups.
Safety and Efficacy of Angiotech Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access
Trial to Assess the Effectiveness of Maintaining Patency and Safety of the Vascular Wrap Paclitaxel-Eluting Mesh After Surgical Implantation With the Lifespan® ePTFE Vascular Graft in the Upper Extremity for Hemodialysis Vascular Access
1 other identifier
interventional
222
1 country
33
Brief Summary
This is a multi-center clinical study in subjects requiring arteriovenous grafts in the upper extremity for hemodialysis access. All subjects will provide informed consent before undergoing any study procedures. The study will consist of multiple subject visits and telephone contacts during the 52 week study period. During the study period subjects must also maintain an appropriate hemodialysis schedule. IDE Number: G060250
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 2007
Typical duration for not_applicable
33 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, 2007
CompletedFirst Submitted
Initial submission to the registry
March 15, 2007
CompletedFirst Posted
Study publicly available on registry
March 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
November 17, 2011
CompletedNovember 17, 2011
October 1, 2011
2.1 years
March 15, 2007
June 8, 2011
October 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time-to-loss of Target Site Primary Patency
Subjects had primary patency at the target site from graft placement until an intervention on the target site occurred. The duration between graft implantation and graft abandonment due to loss of patency at the target site was the "time-to-loss of primary patency." Note: The study was halted early and therefore became underpowered to analyze efficacy as detailed in the protocol.
1 year
Secondary Outcomes (1)
Adverse Events
1 year
Study Arms (2)
Vascular Wrap and Graft
EXPERIMENTALLifespan® 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.
Lifespan® ePTFE Vascular Graft
NO INTERVENTIONLifespan® ePTFE Vascular Graft Only: The Lifespan® ePTFE Vascular Graft is implanted as an arteriovenous graft in an upper extremity to provide a hemodialysis access.
Interventions
0.9 µg/mm\^2 paclitaxel
Eligibility Criteria
You may qualify if:
- be ≥ 18 years of age;
- if female of childbearing potential, provide evidence of a negative pregnancy test within 3 days prior to graft placement (Day -3 to Day 0);
- be a candidate for a new end-to-side arteriovenous anastomosis graft placed in the upper extremity;
- have an outflow vein of greater than or equal to 3 mm in diameter;
- be able to effectively communicate with study personnel;
- be considered by the physician to be available for subsequent visits;
- be willing to comply with all aspects of the treatment and evaluation schedule over a 52 week duration;
- 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;
- sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures;
- 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
- have the Lifespan® ePTFE Vascular Graft successfully implanted.
You may not qualify if:
- pregnant, breast-feeding, or female of childbearing potential who do not agree to remain abstinent or to use a contraceptive method during the study period. Non-childbearing potential is defined as either post-menopausal (amenorrheic for at least 1 year) or surgically sterile. Surgically sterile is defined as tubal ligation or the absence of the uterus and/or ovaries;
- 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;
- a central venous stenosis on the ipsilateral side is documented;
- a hypercoagulable state is documented;
- life expectancy is less than one year;
- an organ transplant is expected within 6 months of test or control product (study products) placement;
- hypersensitivity to any component of the study products or procedural materials or medications is known;
- concurrently involved in another investigational study;
- a study product being investigated by others has been received within 30 days prior to randomization in this trial;
- the study product being studied in this trial has previously been received;
- uncontrolled hypertension with systolic BP \>200mmHg or diastolic BP \>115mmHg is present at screening;
- currently receiving chemotherapy or radiation therapy; or
- placement of a new end-to-end arteriovenous anastomosis graft is required.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Clinical Research Center
Birmingham, Alabama, 35213, United States
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 Cancer Institute
Pensacola, Florida, 32501, United States
Southeastern Urological Center, P.A
Tallahassee, Florida, 32308, 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
Biomedical Research Alliance of New York
The Bronx, New York, 10461, United States
BRANY - Montefiore Medical Center
The Bronx, New York, 10467, United States
Rex Hospital
Raleigh, North Carolina, 27606, United States
Clinical Research of Winston-Salem, Inc.
Winston-Salem, North Carolina, 27103, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45206, 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
Milwaukee, Wisconsin, 53217, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to an observed imbalance in the number of graft infections, enrollment in the 1-year study 012-VWAV06 was suspended at the recommendation of the DSMC. Many of the planned efficacy analyses did not occur as a result of this suspension.
Results Point of Contact
- Title
- Dr. Trudy Estridge
- Organization
- Angiotech Pharmaceuticals
Study Officials
- STUDY CHAIR
Rui Avelar, MD
Angiotech Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
March 15, 2007
First Posted
March 19, 2007
Study Start
March 1, 2007
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
November 17, 2011
Results First Posted
November 17, 2011
Record last verified: 2011-10