Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT (DEXTERITY-AFP)
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 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
- 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: use of highly effective contraception (abstinence is acceptable) for at least 1 month prior to study treatment (unless they had given birth within the 1 month prior to study treatment), and agreement t…
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 HospitalOrange, California
- Vascular Care ConnecticutDarien, Connecticut
- HCA Florida JFK HospitalAtlantis, Florida
- Baptist HealthJacksonville, Florida
- University of South FloridaTampa, Florida
- Piedmont Heart InstituteAtlanta, Georgia