RecruitingPhase 2NCT04858776

Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral DVT

Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral DVT (DEXTERITY-SCI)


Sponsor

Mercator MedSystems, Inc.

Enrollment

60 participants

Start Date

Aug 8, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Perivascular dexamethasone and Perivascular sham for people with iliofemoral; thrombosis. The study is currently recruiting participants at 15 locations. People eligible for this study include aged 18 Years to 89 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTPerivascular dexamethasone

Dexamethasone delivery around target vein segment(s)

COMBINATION_PRODUCTPerivascular 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04858776


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