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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. 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04862468
The ClinicalTrials.gov registry entry for NCT04862468 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mercator MedSystems, which has 7 total studies on file at ClinicalTrials.gov.
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 reports 17 study locations spanning 14 distinct geographic areas - top geographies include 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.
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