Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral DVT (DEXTERITY-SCI)
Mercator MedSystems, Inc.
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
- Age range
- 18–89 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of signed and dated informed consent form prior to receiving any non-standard of care, protocol-specific procedures. 2. Stated willingness to comply with all study procedures including completion of questionnaires and follow-up visits and availability for the duration of the study. 3. Male or female, aged 18 to 89 years. 4. For females of reproductive potential: negative pregnancy test ≤7 days before the procedure, use of highly effective contraception for at least 1 month prior to screening, and agreement to use such a method during study participation. 5. Ne…
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 ConnecticutDarien, Connecticut
- University of South FloridaTampa, Florida
- Northwestern University HospitalChicago, Illinois
- CIS Clinical ResearchHouma, Louisiana
- Medstar Health Research InstituteHyattsville, Maryland
- Stony Brook University HospitalStony Brook, New York