Trials / Recruiting
RecruitingNCT04862468
Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT
Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT (DEXTERITY-AFP)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Mercator MedSystems, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 89 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Perivascular dexamethasone | Dexamethasone delivery around target vein segment(s) |
| COMBINATION_PRODUCT | Perivascular sham | Saline delivery around target vein segment(s) |
Timeline
- Start date
- 2021-10-29
- Primary completion
- 2026-08-01
- Completion
- 2028-02-01
- First posted
- 2021-04-28
- Last updated
- 2025-07-04
Locations
17 sites across 3 countries: United States, Ireland, United Kingdom
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04862468. Inclusion in this directory is not an endorsement.