Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT

NCT04862468 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 80 participants
Start Date 2021-10-29
Est. Completion 2028-02-01
Phase Phase 2

Sponsor

Mercator MedSystems

3 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04862468 reports 17 study locations spanning 14 distinct geographic areas — top geographies include Florida, Other, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04862468?

The interventions under investigation include: Perivascular dexamethasone (COMBINATION_PRODUCT), Perivascular sham (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04862468?

This trial is sponsored by Mercator MedSystems, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial