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Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral DVT

NCT04858776 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-10-18

No results posted yet for this 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 at least 14 days and no more than 60 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

  • Iliofemoral; Thrombosis

Interventions

COMBINATION_PRODUCT

Perivascular dexamethasone

Dexamethasone delivery around target vein segment(s)

COMBINATION_PRODUCT

Perivascular sham

Saline delivery around target vein segment(s)

Sponsors & Collaborators

  • Mercator MedSystems, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-08
Primary Completion
2025-05-31
Completion
2026-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Ireland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04858776 on ClinicalTrials.gov