Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT
Sponsor: Mercator MedSystems, Inc. • ClinicalTrials.gov ID: NCT04862468
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This is a study of a medical procedure that utilizes a commercially available catheter (the Bullfrog® Micro-Infusion Device) to locally deliver a commercially available anti-inflammatory drug (dexamethasone sodium phosphate injection) around the deep veins after DVT recanalization, where DVT symptoms were present for up to 14 days prior to recanalization. The goal of the study is to see if local anti-inflammation helps prevent re-thrombosis of the blood vessel and improvement in symptoms for up to 24 months after the initial DVT recanalization procedure.
Interventions
-
Perivascular dexamethasone
(Combination product)
Dexamethasone delivery around target vein segment(s)
-
Perivascular sham
(Combination product)
Saline delivery around target vein segment(s)
Eligibility criteria
Conditions
Locations
- HonorHealth — Scottsdale, Arizona, United States
- Providence St. Joseph Hospital — Orange, California, United States
- Vascular Care Connecticut — Darien, Connecticut, United States
- HCA Florida JFK Hospital — Atlantis, Florida, United States
- Baptist Health — Jacksonville, Florida, United States
- University of South Florida — Tampa, Florida, United States
- Grady Memorial Hospital — Atlanta, Georgia, United States
- Piedmont Heart Institute — Atlanta, Georgia, United States
- CIS Clinical Research — Houma, Louisiana, United States
- Medstar Health Research Institute — Hyattsville, Maryland, United States
- Englewood Health — Englewood, New Jersey, United States
- Stony Brook University Hospital — Stony Brook, New York, United States
- NC Heart and Vascular Research — Raleigh, North Carolina, United States
- OhioHealth Research Institute — Columbus, Ohio, United States
- Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
- HCA Medical City Arlington — Arlington, Texas, United States
- HCA Houston Healthcare Medical Center — Houston, Texas, United States
- Baylor Scott & White Hospital — Plano, Texas, United States
- Sentara Norfolk General Hospital — Norfolk, Virginia, United States
- UW Medical Center - Northwest — Seattle, Washington, United States
- Galway University Hospital — Galway, Ireland
- Guy's and St. Thomas Hospital — London, United Kingdom
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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