drugset / Trial / NCT04858776

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

NCT04858776 ↗

Phase 2 Active not recruiting 60 enrolled Mercator MedSystems, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2022-08-08
Primary completion
2025-08-28
Completion
2027-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule — Other