Actively Recruiting
Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT
Led by Mercator MedSystems, Inc. · Updated on 2025-07-04
80
Participants Needed
17
Research Sites
326 weeks
Total Duration
On this page
Sponsors
M
Mercator MedSystems, Inc.
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study-specific procedures
- Willingness to comply with all study procedures, questionnaires, and follow-up visits
- Male or female aged 18 to 89 years
- For females of childbearing potential: using effective contraception or abstinence for at least 1 month before and 30 days after treatment
- Acute DVT symptoms started 14 days or less before intervention
- Ability to take oral medication and willingness to follow prescribed anticoagulant regimen
- Post-procedure prescription of low molecular weight heparin for at least 28 days followed by therapeutic anticoagulant for minimum 12 months
- At least 28 days of prescribed antiplatelet agent for patients with stents
- DVT located in major femoropopliteal veins, with possible iliac vein extension
- Successful removal of acute thrombus and vein recanalization
You will not qualify if you...
- Currently enrolled in another clinical study with ongoing primary endpoint
- Unable to understand the clinical trial's nature and implications
- BMI between 40 and 45 kg/m2 with significant comorbidity affecting study outcomes
- BMI over 45 kg/m2
- Non-ambulatory before DVT
- Established post-thrombotic syndrome or symptomatic deep venous insufficiency in study leg lasting over 14 days
- Previous symptomatic DVT in study leg within last year
- Symptomatic DVT in the opposite leg expected to require surgery within 30 days
- Severe circulatory compromise or low ankle/toe pressures
- Massive or intermediate high-risk pulmonary embolism
- Unable to tolerate venous intervention due to severe illness
- Allergy or hypersensitivity to planned drugs except mild contrast allergies with steroid premedication
- History or active heparin-induced thrombocytopenia
- Hemoglobin below 8.0 g/dl
- INR above 1.6 before anticoagulation
- Platelet count below 100,000/ml
- Severe kidney impairment
- Active or recent bleeding, severe liver dysfunction, or bleeding disorders
- Recent eye surgery or hemorrhagic retinopathy
- Recent major surgery or trauma within 10 days
- Childbirth less than 72 hours before procedure
- Hemorrhagic stroke or intracranial bleeding/tumor/vascular malformation/aneurysm within last year
- Active symptomatic COVID-19 impairing study outcomes
- Severe hypertension not stabilized before venous access
- Pregnant or breastfeeding
- Life expectancy under 2 years
- Major thrombus in inferior vena cava extending above common iliac vein
- Unable to obtain venous access or recanalize vein with less than 30% obstruction
- History of ipsilateral venous stent
- DVT target length for treatment exceeds 50 cm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Providence St. Joseph Hospital
Orange, California, United States, 92868
Actively Recruiting
2
Vascular Care Connecticut
Darien, Connecticut, United States, 06820
Actively Recruiting
3
HCA Florida JFK Hospital
Atlantis, Florida, United States, 33462
Actively Recruiting
4
Baptist Health
Jacksonville, Florida, United States, 32258
Actively Recruiting
5
University of South Florida
Tampa, Florida, United States, 33060
Actively Recruiting
6
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Actively Recruiting
7
CIS Clinical Research
Houma, Louisiana, United States, 70360
Actively Recruiting
8
Medstar Health Research Institute
Hyattsville, Maryland, United States, 20782
Actively Recruiting
9
Englewood Health
Englewood, New Jersey, United States, 07631
Actively Recruiting
10
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Actively Recruiting
11
NC Heart and Vascular Research
Raleigh, North Carolina, United States, 27607
Actively Recruiting
12
OhioHealth Research Institute
Columbus, Ohio, United States, 43214
Active, Not Recruiting
13
St John Health System
Bartlesville, Oklahoma, United States, 74006
Active, Not Recruiting
14
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
15
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23452
Actively Recruiting
16
Galway University Hospital
Galway, Ireland, H91 YR71
Completed
17
Guy's and St. Thomas Hospital
London, United Kingdom, SE1 7EH
Active, Not Recruiting
Research Team
K
Kirk Seward, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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