Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation after Thrombus Removal to Yield Benefit in Acute Femoropopliteal (AFP) or in Subacute and Chronic Iliofemoral (SCI) DVT
The DEXTERITY-AFP and DEXTERITY-SCI trials are each multi-site, two-phase trials to examine the effect of Bullfrog® Micro-Infusion Device perivenous injection of dexamethasone sodium phosphate injection, USP, to improve 6-month patency after thrombectomy and stenting in symptomatic deep vein thrombosis with infrainguinal extension and late presentation (14-60 days post symptom onset).
In the first phase (the Lead-in Phase) of each trial, 20 participants will be enrolled, and all will be treated with dexamethasone. After that, the second phase (the RCT Phase) of the -AFP trial will enroll 60 participants and the -SCI trial will enroll 40 participants, each in a 1:1 randomization receiving either dexamethasone (treatment) or sham saline (control) injections.
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