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RECRUITING
NCT04858776
PHASE2

Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral 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 at least 14 days and no more than 60 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 Subacute and Chronic Iliofemoral DVT (DEXTERITY-SCI)

Key Details

Gender

All

Age Range

18 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2022-08-08

Completion Date

2026-12-31

Last Updated

2023-10-18

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 (15)

Vascular Care Connecticut

Darien, Connecticut, United States

University of South Florida

Tampa, Florida, United States

Northwestern University Hospital

Chicago, Illinois, United States

CIS Clinical Research

Houma, Louisiana, United States

Medstar Health Research Institute

Hyattsville, Maryland, 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

CardioVoyage

Denison, Texas, United States

University of Texas, Houston

Houston, Texas, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Lake Washington Vascular

Bellevue, Washington, United States

Galway University Hospital

Galway, Ireland

Guy's and St. Thomas Hospital

London, United Kingdom