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

Conditions

• Iliofemoral; Thrombosis
• Thrombosis, Deep Vein

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 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.

Key Dates

Start date

Oct 29, 2021

Status verified

Jul 2025

Primary completion

Aug 1, 2026

Completion

Feb 1, 2028

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment
• Sham Comparator: Control

Primary Outcome Measure

Rate of clinically relevant primary patency [ Time Frame: 6 months ]

Central Contacts

• Kirk Seward, PhD
  510-614-4550
  [email protected]

Locations (15)

Find similar trials in Orange, CA

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