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

Part of paid clinical trials in Darien, Connecticut.

Sponsor
Mercator MedSystems, Inc.
Study ID
NCT04858776
Phase
PHASE2
Status
Recruiting
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Conditions

  • Iliofemoral; Thrombosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Perivascular dexamethasone — COMBINATION_PRODUCT
    Dexamethasone delivery around target vein segment(s)
  • Perivascular sham — COMBINATION_PRODUCT
    Saline delivery around target vein segment(s)

Study Details

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.

Key Dates

Start date
Aug 8, 2022
Status verified
Oct 2023
Primary completion
May 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
  • Sham Comparator: Control

Primary Outcome Measure

Clinically relevant primary patency [ Time Frame: 6 months ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Vascular Care ConnecticutDarienConnecticut06820-
University of South FloridaTampaFlorida33060-
Northwestern University HospitalChicagoIllinois60611-
CIS Clinical ResearchHoumaLouisiana70360-
Medstar Health Research InstituteHyattsvilleMaryland20782-
Stony Brook University HospitalStony BrookNew York11794-
NC Heart and Vascular ResearchRaleighNorth Carolina27607-
OhioHealth Research InstituteColumbusOhio43214-
St John Health SystemBartlesvilleOklahoma74006-
CardioVoyageDenisonTexas75020-
University of Texas, HoustonHoustonTexas77494-
Sentara Norfolk General HospitalNorfolkVirginia23452-
Lake Washington VascularBellevueWashington98004-

Find similar trials in Darien, CT

By research site
Vascular Care Connecticut· Darien, CTUniversity of South Florida· Tampa, FLNorthwestern University Hospital· Chicago, ILCIS Clinical Research· Houma, LAMedstar Health Research Institute· Hyattsville, MDStony Brook University Hospital· Stony Brook, NY

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