drugset / Trial / NCT04862468

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

NCT04862468 ↗

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 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.

Timeline

Start
2021-10-29
Primary completion
2026-08-01
Completion
2028-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule — Other