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

Stopped early · Not applicable

Conditions studied: End Stage Renal Failure on Dialysis, Hyperplasia

In brief

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).

Key facts

Study ID

NCT01033357

Run by

Angiotech Pharmaceuticals

People needed

222

Starts

2008-03-01

Expected to finish

2010-10-01

Last updated by the study team

2013-02-11

Who can join

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

You may not qualify if…

• Subjects who withdrew or were withdrawn from study 012-VWAV06.

Where it is running

• 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 Hospital — Pensacola, 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
• BRANY - Montefiore Medical Center — The Bronx, New York, United States
• Rex Healthcare — 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

Full record on ClinicalTrials.gov

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