FDA-Mandated study tracks safety of dialysis access device for five years
NCT ID NCT04543539
Summary
This study is monitoring the long-term safety of a drug-coated balloon used to open blocked or narrowed blood vessels in dialysis access fistulas in the arm. It will follow 240 patients for five years to check for serious infections and other safety issues. The study is required by the FDA after the device's initial approval to ensure its continued safe use.
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Contacts and locations
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Locations
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Albany Medical College
Albany, New York, 12084, United States
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Cedars-Sinai Heart Institute
Los Angeles, California, 90048, United States
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Coastal Vascular and Interventional
Pensacola, Florida, 32504, United States
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FirstHealth of the Carolinas
Pinehurst, North Carolina, 28374, United States
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Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
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Lancaster General Hospital
Lancaster, Pennsylvania, 17602, United States
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MUSC Health Dialysis Access Institute
Orangeburg, South Carolina, 29118, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Medstar Washington Hospital
Washington D.C., District of Columbia, 20010, United States
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NCH Healthcare System
Naples, Florida, 34102, United States
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Oregon Health & Science University Hospital
Portland, Oregon, 97239, United States
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Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
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Stanford University Medical Center
Stanford, California, 94301, United States
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Staten Island University Hospital
Staten Island, New York, 10305, United States
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The Mount Sinai Hospital
New York, New York, 10029, United States
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University of Iowa
Iowa City, Iowa, 52242, United States
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University of Michigan Health System - University Hospital
Ann Arbor, Michigan, 48109, United States
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University of Virginia Medical Center
Charlottesville, Virginia, 22903, United States
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University of Wisconsin-Madison - Meriter Hospital
Madison, Wisconsin, 53713, United States
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Yale New Haven Hospital
New Haven, Connecticut, 06519, United States
Conditions
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