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RECRUITING
NCT04862468
PHASE2

Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT

Sponsor: Mercator MedSystems, Inc.

View on ClinicalTrials.gov

Summary

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.

Official title: Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT (DEXTERITY-AFP)

Key Details

Gender

All

Age Range

18 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2021-10-29

Completion Date

2028-02-01

Last Updated

2025-07-04

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Perivascular dexamethasone

Dexamethasone delivery around target vein segment(s)

COMBINATION_PRODUCT

Perivascular sham

Saline delivery around target vein segment(s)

Locations (17)

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

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

St John Health System

Bartlesville, Oklahoma, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Galway University Hospital

Galway, Ireland

Guy's and St. Thomas Hospital

London, United Kingdom