Safety and Efficacy of Angiotech Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access

Stopped early · Not applicable

Conditions studied: Kidney Diseases, ESRD

In brief

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

Key facts

Study ID

NCT00448708

Run by

Angiotech Pharmaceuticals

People needed

222

Starts

2007-03-01

Expected to finish

2009-04-01

Last updated by the study team

2011-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.