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NCT04862468 · ClinicalTrials.gov registry record · Phase 2
Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT
A Phase 2 study of Iliofemoral; Thrombosis and Thrombosis, Deep Vein, sponsored by Mercator MedSystems.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 17
- Study locations
NCT04862468: Recruiting Phase 2 study of Iliofemoral; Thrombosis and Thrombosis, Deep Vein, sponsored by Mercator MedSystems.
NCT04862468 is a Phase 2 study of Iliofemoral; Thrombosis and Thrombosis, Deep Vein that is actively recruiting participants, run by Mercator MedSystems. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). The trial reports 17 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04862468, a Phase 2 study of Iliofemoral; Thrombosis and Thrombosis, Deep Vein, is actively recruiting participants, sponsored by Mercator MedSystems.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 17
- Study locations
Study 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.
Primary Outcome
Rate of freedom from loss of patency (defined as 100% occlusion of unstented vein or 50% stenosis of stented vein measured by duplex ultrasound or angiogram) with associated symptoms
Conditions Studied
Interventions
- COMBINATION_PRODUCT Perivascular dexamethasone
- COMBINATION_PRODUCT Perivascular sham
Study Locations (17)
Florida
- HCA Florida JFK Hospital - Atlantis
- Baptist Health - Jacksonville
- University of South Florida - Tampa
Other
- Galway University Hospital - Galway
- Guy's and St. Thomas Hospital - London
California
- Providence St. Joseph Hospital - Orange
Connecticut
- Vascular Care Connecticut - Darien
Georgia
- Piedmont Heart Institute - Atlanta
Louisiana
- CIS Clinical Research - Houma
Maryland
- Medstar Health Research Institute - Hyattsville
New Jersey
- Englewood Health - Englewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2021-10-29 |
| Est. Completion | 2028-02-01 |
| Phase | Phase 2 |
What NCT04862468 shows while recruiting
NCT04862468 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 2 conditions, with Iliofemoral; Thrombosis appearing as the primary indexed condition, and to 2 interventions - of which Perivascular dexamethasone is the first listed.
NCT04862468 lists 17 locations in 14 states (Florida, Other, California).
Frequently Asked Questions
What is clinical trial NCT04862468 about?
NCT04862468 is a clinical study titled "Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT". 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 symptom...
What is the current status of trial NCT04862468?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2021-10-29. Estimated completion is 2028-02-01.
What conditions does trial NCT04862468 study?
This clinical trial studies the following conditions: Iliofemoral; Thrombosis, Thrombosis, Deep Vein.
What interventions are being tested in trial NCT04862468?
The interventions under investigation include: Perivascular dexamethasone (COMBINATION_PRODUCT), Perivascular sham (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04862468?
This trial is sponsored by Mercator MedSystems, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04862468 being conducted?
This trial has 17 study locations across California, Connecticut, Florida, Georgia, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04862468's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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