RecruitingPhase 2NCT04862468

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

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

Sponsor

Mercator MedSystems, Inc.

Enrollment

80 participants

Start Date

Oct 29, 2021

Study Type

INTERVENTIONAL

Conditions

Thrombosis, Deep Vein Iliofemoral; Thrombosis

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.

Eligibility

Min Age: 18 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether injecting a steroid (dexamethasone) around the vein during a clot-removal procedure (thrombectomy) helps reduce inflammation and improve long-term outcomes for people with a type of deep vein blood clot (DVT) in the leg. **You may be eligible if...** - You are between 18 and 89 years old - You have been diagnosed with a deep vein thrombosis (blood clot) in your femoral or popliteal vein (upper or lower leg vein) - You are willing to follow the study schedule and attend follow-up visits - You (if female and of childbearing potential) are using effective contraception **You may NOT be eligible if...** - You have certain health conditions that make dexamethasone unsafe - You are unwilling to comply with study procedures Talk to your doctor to see if this trial is right for you.

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(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

View Full Details on ClinicalTrials.gov

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NCT04862468

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